Counter (Beta, Gamma) For Clinical Use
FDA product code JJJ · Class I (low risk) · 21 CFR 862.2320 · Clinical Chemistry
63510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Beckman Instruments, Inc. 7
- Kemble Instruments, Inc. 6
- Lkb Instruments, Inc. 5
- Abbott Laboratories 4
- Micromedic Systems 4
- Medical & Scientific Designs, Inc. 3
- Actus, Inc. 3
- Iso-Data, Inc. 3
- Nuclear Ent. , Ltd. 3
- Laboratory Technologies, Inc. 2
- Capintec, Inc. 2
- Nuclear Medical Laboratories, Inc. 2
- G.D. Searle and Co. 2
- Innotron of Oregon, Inc. 1
- New England Nuclear 1
- Philips Medical Systems (Cleveland) Inc 1
- Roche Medical Electronics, Inc. 1
- E. R. Squibb & Sons, Inc. 1
- Biotraces, Inc. 1
- Miles Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962762 | Sequential Sample Multi-Photon DetectorJJJ · Traditional | Biotraces, Inc. | 08/16/1996SE |
| K946387 | Capra (Caprac-R) Wipetest and Well CounterJJJ · Traditional | Capintec, Inc. | 03/30/1995SE |
| K920559 | Abbott Vertex AnalyzerJJJ · Traditional | Abbott Laboratories | 03/19/1992SE |
| K900087 | Genesys 6000 Gamma CounterJJJ · Traditional | Laboratory Technologies, Inc. | 07/19/1990SE |
| K896202 | MATRIX(TM)-96JJJ · Traditional | Canberra Industries, Inc. | 01/02/1990SE |
| K894902 | SourcererJJJ · Traditional | Oakfield Instruments, Ltd. | 10/17/1989SE |
| K884091 | SourcererJJJ · Traditional | John Caunt Scientific , Ltd. | 02/02/1989SE |
| K884269 | Sample Identification Station Model 38010JJJ · Traditional | Icn Micromedic Systems | 01/09/1989SE |
| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | Lkb Instruments, Inc. | 11/04/1987SE |
| K872430 | Iso-Data 500 Series Gamma CounterJJJ · Traditional | Iso-Data, Inc. | 08/21/1987SE |
| K872429 | Iso-Data 100 Series Gamma CounterJJJ · Traditional | Iso-Data, Inc. | 08/21/1987SE |
| K870115 | Berthold LB 2103,2104-XT/PC/AT,951G Gamma CountersJJJ · Traditional | Berthold Analytical Instruments, Inc. | 03/31/1987SE |
| K862206 | Taurus (TM) Automatic Liquid Scintillation CounterJJJ · Traditional | Micromedic Systems | 08/04/1986SE |
| K851164 | Dentocult Culture-PaddleJJJ · Traditional | Orion Corp. | 10/29/1985SE |
| K851689 | Genesys Gamma CounterJJJ · Traditional | Laboratory Technologies, Inc. | 08/07/1985SE |
| K852434 | 1208 Betacord and 1208 Betcord MJJJ · Traditional | Lkb Instruments, Inc. | 08/02/1985SE |
| K842902 | Microstat Gamma CounterJJJ · Traditional | Micromedic Systems | 08/09/1984SE |
| K841352 | ND1200 Ria CounterJJJ · Traditional | Nuclear Data, Inc. | 05/02/1984SE |
| K834508 | Corning 4000 Multi-Well Gamma CounterJJJ · Traditional | Corning Medical & Scientific | 03/16/1984SE |
| K832734 | Kemtek 400 Ria Gamma CounterJJJ · Traditional | Kemble Instruments, Inc. | 10/14/1983SE |
| K832736 | Kemtek 104 Ria Gamma CounterJJJ · Traditional | Kemble Instruments, Inc. | 09/29/1983SE |
| K832735 | Kemtek 103 Ria Gamma CounterJJJ · Traditional | Kemble Instruments, Inc. | 09/29/1983SE |
| K832210 | Gamma Photon Gamma CounterJJJ · Traditional | Medical & Scientific Designs, Inc. | 08/24/1983SE |
| K832209 | Kineti Count 24 Gamma CounterJJJ · Traditional | Medical & Scientific Designs, Inc. | 08/24/1983SE |
| K832002 | NML-5010/5020 Multi-Detector SystemJJJ · Traditional | Nuclear Medical Laboratories, Inc. | 08/08/1983SE |
| K830751 | Kemtek 102JJJ · Traditional | Kemble Instruments, Inc. | 04/06/1983SE |
| K830365 | Kineti Count 48 Immunoassay SystemJJJ · Traditional | Medical & Scientific Designs, Inc. | 03/10/1983SE |
| K823240 | Cap-Ria 16JJJ · Traditional | Capintec, Inc. | 12/03/1982SE |
| K822293 | Immu-Count 404JJJ · Traditional | Kemble Instruments, Inc. | 08/24/1982SE |
| K821892 | Phillips Radiation Measuring InstrumentJJJ · Traditional | Long Island Scientific | 07/13/1982SE |
| K821494 | Ria Stat 16JJJ · Traditional | E. R. Squibb & Sons, Inc. | 06/03/1982SE |
| K820376 | Micromedic Systems IsoflexJJJ · Traditional | Micromedic Systems | 03/16/1982SE |
| K820137 | Immu-CountJJJ · Traditional | Kemble Instruments, Inc. | 02/05/1982SE |
| K813472 | LS 5800 Series Liquid ScintillationJJJ · Traditional | Beckman Instruments, Inc. | 12/29/1981SE |
| K810345 | Liquid Scintillation SpectrophotometerJJJ · Traditional | Beckman Instruments, Inc. | 02/25/1981SE |
| K802578 | PACE-4-AUTOMATIC Ria Gamma-CouterJJJ · Traditional | Philips Medical Systems (Cleveland), Inc. | 12/18/1980SE |
| K801264 | Nuclear Enterprises 1600/GAMMA CounterJJJ · Traditional | Nuclear Ent. , Ltd. | 06/26/1980SE |
| K801263 | Nuclear Enterprises 1612 Multi-WellJJJ · Traditional | Nuclear Ent. , Ltd. | 06/20/1980SE |
| K801245 | Atomlight (Liquid Scintillation SolutionJJJ · Traditional | New England Nuclear | 06/20/1980SE |
| K800601 | Hydragamma 16JJJ · Traditional | Innotron of Oregon, Inc. | 04/10/1980SE |
| K800388 | NML 5000 Auto. Gamma Scint. CounterJJJ · Traditional | Nuclear Medical Laboratories, Inc. | 03/12/1980SE |
| K790961 | Liquid Scintillation CounterJJJ · Traditional | Nuclear Ent. , Ltd. | 06/28/1979SE |
| K790905 | Nuclear Sample ReaderJJJ · Traditional | Abbott Laboratories | 06/15/1979SE |
| K780790 | Idi 200 Gamma CounterJJJ · Traditional | Iso-Data, Inc. | 06/22/1978SE |
| K780341 | Scintillation, Liquid, RackbetaJJJ · Traditional | Lkb Instruments, Inc. | 05/26/1978SE |
| K780344 | Gamma CounterJJJ · Traditional | Lkb Instruments, Inc. | 04/12/1978SE |
| K771614 | Auto. Well Type Gamma CountersJJJ · Traditional | Actus, Inc. | 04/12/1978SE |
| K771613 | Well Type Gamma CounterJJJ · Traditional | Actus, Inc. | 04/10/1978SE |
| K771612 | Well Type Gamma CounterJJJ · Traditional | Actus, Inc. | 04/10/1978SE |
| K780383 | Counter, Radioassay, Auto., MicromedicJJJ · Traditional | Micromedic Systems | 03/22/1978SE |
| K780179 | Liquid Scintillation CounterJJJ · Traditional | Roche Medical Electronics, Inc. | 02/23/1978SE |
| K772099 | PrinterJJJ · Traditional | Miles Laboratories, Inc. | 01/26/1978SE |
| K771369 | Liq. Scintillation SpectrophotometeoJJJ · Traditional | Beckman Instruments, Inc. | 09/14/1977SE |
| K771129 | Auto-Logic II SystemJJJ · Traditional | Abbott Laboratories | 08/04/1977SE |
| K771180 | Gamma Gounting Sys., Auto, Model 1400JJJ · Traditional | G.D. Searle and Co. | 08/03/1977SE |
| K770740 | Radioassay Tubes & Radioassay Tube CapsJJJ · Traditional | G.D. Searle and Co. | 06/22/1977SE |
| K770572 | DP-5000 Data Reduction SystemJJJ · Traditional | Beckman Instruments, Inc. | 04/15/1977SE |
| K770088 | Gamma 4000 Scintillation CounterJJJ · Traditional | Beckman Instruments, Inc. | 02/14/1977SE |
| K761214 | Well Counters, Logic II (200 Series)JJJ · Traditional | Abbott Laboratories | 12/16/1976SE |
| K760900 | Gamma Scintillation CounterJJJ · Traditional | Beckman Instruments, Inc. | 11/16/1976SE |
| K760424 | Liquid Scintillation CounterJJJ · Traditional | Beckman Instruments, Inc. | 11/02/1976SE |
| K760828 | Blastomyces Yeast AntigenJJJ · Traditional | I M, Inc. | 11/01/1976SE |
| K760470 | Counter, Rack Gamma (#1270)JJJ · Traditional | Lkb Instruments, Inc. | 11/01/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0638-2016 Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 The Wizard…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | Perkinelmer | 12/08/2015Terminated |
| Z-0637-2016 Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 3470-0200. The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | Perkinelmer | 12/08/2015Terminated |
| Z-0636-2016 Class II | Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-0150 The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | Perkinelmer | 12/08/2015Terminated |
| Z-0635-2016 Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100. The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | Perkinelmer | 12/08/2015Terminated |
| Z-0634-2016 Class II | Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050. The…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | Perkinelmer | 12/08/2015Terminated |
| Z-0633-2016 Class II | Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard gamma…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | Perkinelmer | 12/08/2015Terminated |
| Z-0632-2016 Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard gamma…The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second… | Perkinelmer | 12/08/2015Terminated |
| Z-2130-2015 Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard"…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Perkinelmer | 06/03/2015Terminated |
| Z-2129-2015 Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Perkinelmer | 06/03/2015Terminated |
| Z-2128-2015 Class II | Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Perkinelmer | 06/03/2015Terminated |
| Z-2127-2015 Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Perkinelmer | 06/03/2015Terminated |
| Z-2126-2015 Class II | WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard" gamma…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Perkinelmer | 06/03/2015Terminated |
| Z-2125-2015 Class II | WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard" gamma counter is…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Perkinelmer | 06/03/2015Terminated |
| Z-2124-2015 Class II | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard" gamma…Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results | Perkinelmer | 06/03/2015Terminated |