Device, Microtiter Diluting/Dispensing
FDA product code JTC · Class I (low risk) · 21 CFR 866.2500 · Microbiology
66510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Dynatech Laboratories, Inc. 12
- Dynatech Corp. 6
- Corning Costar Corp. 5
- Flow Laboratories, Inc. 5
- Genetic Systems Corp. 4
- Skatron, Inc. 3
- Bio-Tek Instruments, Inc. 3
- Plastic Injectors, Inc. 3
- Hamilton Co. 3
- Organon Teknika Corp. 3
- Analytical Products, Inc. 2
- Packard Instrument Co., Inc. 2
- Slt Labinstruments, Inc. 2
- Microtech Medical Systems, Inc. 2
- Beckman Instruments, Inc. 1
- Biomerieux Inc 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Micromedic Systems 1
- Remel Co. 1
- Amt Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924907 | Filtermate Universal HarvesterJTC · Traditional | Packard Instrument Co., Inc. | 12/01/1992SE |
| K901808 | Micromate 196 Model A961960JTC · Traditional | Packard Instrument Co., Inc. | 06/20/1990SE |
| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | Dynatech Laboratories, Inc. | 10/17/1989SE |
| K892369 | Multi-Probe Head PlusJTC · Traditional | Hamilton Co. | 06/02/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K884695 | Washer 500 Microelisa SystemJTC · Traditional | Organon Teknika Corp. | 12/13/1988SE |
| K884125 | Bio-Tek Automated Microplate Washer Model EL403JTC · Traditional | Bio-Tek Instruments, Inc. | 12/02/1988SE |
| K874598 | Dynatech MR 250 Manual Microelisa ReaderJTC · Traditional | Dynatech Laboratories, Inc. | 11/20/1987SE |
| K873542 | Microplate Auto-Washer (Motorized Stage)JTC · Traditional | Genetic Systems Corp. | 09/23/1987SE |
| K871945 | Microlab atJTC · Traditional | Hamilton Co. | 05/29/1987SE |
| K863423 | Code-A-Well Series 1-1000 and Series 1-1100JTC · Traditional | Plastic Injectors, Inc. | 09/16/1986SE |
| K863374 | Code-A-Well Series 1-600, 1-625JTC · Traditional | Plastic Injectors, Inc. | 09/11/1986SE |
| K862802 | Multi-Channel MicropipettesJTC · Traditional | Dynatech Laboratories, Inc. | 08/01/1986SE |
| K862066 | Titertek Microplate Washer S-12JTC · Traditional | Flow Laboratories, Inc. | 06/05/1986SE |
| K860617 | PolypetJTC · Traditional | Instrumed, Inc. | 03/03/1986SE |
| K853920 | Bio-Tek El 401 Handheld Microplate WasherJTC · Traditional | Bio-Tek Instruments, Inc. | 10/22/1985SE |
| K853380 | SPR 2 AutodiluterJTC · Traditional | Scientific Sales Intl., Inc. | 09/12/1985SE |
| K851020 | Mic-Concept InoculatorJTC · Traditional | Microtech Medical Systems, Inc. | 03/29/1985SE |
| K851019 | Mic-Concept Inoculum Seed TrayJTC · Traditional | Microtech Medical Systems, Inc. | 03/29/1985SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | Flow Laboratories, Inc. | 03/25/1985SE |
| K850249 | Bio-Tek Automated Microplate Washer EL402JTC · Traditional | Bio-Tek Instruments, Inc. | 03/13/1985SE |
| K850371 | Intiwash Manual Microplate WasherJTC · Traditional | Inti Corp. | 03/11/1985SE |
| K844893 | SLT 223 Dispenser for MicrotiterplatesJTC · Traditional | Slt Labinstruments, Inc. | 02/25/1985SE |
| K844891 | SLT 225 Washer/Dispenser for Micro TiterplatesJTC · Traditional | Slt Labinstruments, Inc. | 02/25/1985SE |
| K844568 | Titertek Duluter/Dispenser 78-640-00JTC · Traditional | Flow Laboratories, Inc. | 01/30/1985SE |
| K844552 | Bio-Stat III Plate WasherJTC · Traditional | Whittaker Bioproducts, Inc. | 01/30/1985SE |
| K844500 | Titertek Microplate Washer 120JTC · Traditional | Flow Laboratories, Inc. | 01/22/1985SE |
| K843272 | T.I.M.E. DispenserJTC · Traditional | Dynatech Laboratories, Inc. | 09/14/1984SE |
| K842848 | Code-A-Well 350 Microtitration StripsJTC · Traditional | Plastic Injectors, Inc. | 09/07/1984SE |
| K831462 | Api Uniscept Plus 140 InoculatorJTC · Traditional | Analytical Products, Inc. | 08/12/1983SE |
| K832203 | Multi-Titer DispenserJTC · Traditional | Hamilton Co. | 08/08/1983SE |
| K831640 | Washer 6000 Micro-C Lisa SystemJTC · Traditional | Organon Teknika Corp. | 08/08/1983SE |
| K831644 | Pipette 12 ChannelJTC · Traditional | Organon Teknika Corp. | 08/01/1983SE |
| K831341 | Api Uniscept Plus AutoinoculatorJTC · Traditional | Analytical Products, Inc. | 06/02/1983SE |
| K830059 | Mueller Hinton W/50% Sheep BloodJTC · Traditional | bioMerieux, Inc. | 02/09/1983SE |
| K823137 | OctapettesJTC · Traditional | Corning Costar Corp. | 12/03/1982SE |
| K823218 | Disposable Dispense ManifoldJTC · Traditional | Dynatech Laboratories, Inc. | 11/16/1982SE |
| K821961 | 96 Well DispenserJTC · Traditional | Skatron, Inc. | 07/22/1982SE |
| K820992 | Microplate Washing DeviceJTC · Traditional | Skatron, Inc. | 05/03/1982SE |
| K820821 | MIC-2000 Plus, 96 Channel DispenserJTC · Traditional | Dynatech Corp. | 04/14/1982SE |
| K812860 | Immunoassay PlateJTC · Traditional | Skatron, Inc. | 10/26/1981SE |
| K812818 | Titertek AutodropJTC · Traditional | Flow Laboratories, Inc. | 10/23/1981SE |
| K810719 | Replica PlaterJTC · Traditional | Dynatech Corp. | 04/01/1981SE |
| K810659 | Autodiluter IIIJTC · Traditional | Dynatech Corp. | 03/31/1981SE |
| K810229 | Sceptor System Automated Model 216JTC · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/09/1981SE |
| K803244 | Assay StripsJTC · Traditional | Corning Costar Corp. | 02/02/1981SE |
| K810039 | MIC-2000 Inoculum Tray LidJTC · Traditional | Dynatech Corp. | 01/28/1981SE |
| K803243 | Serocluster Flexible Vinyl U & V Pl.JTC · Traditional | Corning Costar Corp. | 01/28/1981SE |
| K803242 | Serocluster Eia PlatesJTC · Traditional | Corning Costar Corp. | 01/28/1981SE |
| K810022 | SRD IIIJTC · Traditional | Dynatech Corp. | 01/26/1981SE |
| K803252 | Micromedic Reagent DispenserJTC · Traditional | Micromedic Systems | 01/12/1981SE |
| K802857 | Immulon Removawell Strips #011-010-6301JTC · Traditional | Dynatech Corp. | 12/11/1980SE |
| K801305 | Hippurate DiskJTC · Traditional | Remel Co. | 07/21/1980SE |
| K801437 | Dispensing Serological PipetJTC · Traditional | Amt Corp. | 07/14/1980SE |
| K800989 | Dynawasher IIJTC · Traditional | Dynatech Laboratories, Inc. | 06/02/1980SE |
| K800240 | Serocluster U and VJTC · Traditional | Corning Costar Corp. | 02/13/1980SE |
| K790974 | MIC-2000 Inoculator TemplateJTC · Traditional | Dynatech Laboratories, Inc. | 06/20/1979SE |
| K790971 | MIC-2000 Quad Inoculum TrayJTC · Traditional | Dynatech Laboratories, Inc. | 06/20/1979SE |
| K790957 | Histo-DispenserJTC · Traditional | Dynatech Laboratories, Inc. | 06/15/1979SE |
| K790956 | Histo-OilerJTC · Traditional | Dynatech Laboratories, Inc. | 06/15/1979SE |
| K790076 | Inoculator, MIC-2000 DisposableJTC · Traditional | Dynatech Laboratories, Inc. | 02/01/1979SE |
| K781802 | Washer System, MicroelisaJTC · Traditional | Metrix Teknika, Inc. | 12/20/1978SE |
| K781942 | MiniwashJTC · Traditional | Dynatech Laboratories, Inc. | 12/04/1978SE |
| K761149 | Model 203 DispenserJTC · Traditional | Beckman Instruments, Inc. | 12/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1415-2023 Class II | BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software version 5.1 and 5.1.1 as…Upon installation of BD Kiestra" InoqulA+" and BeA version 5.1 and 5.1.1 as part of the Icefall A platform… | Becton Dickinson & Co. | 03/22/2023Open, Classified |
| Z-2439-2019 Class II | BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog…An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch… | Becton Dickinson & Co. | 07/26/2019Terminated |
| Z-2438-2019 Class II | BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog…An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch… | Becton Dickinson & Co. | 07/26/2019Terminated |
| Z-2131-2013 Class III | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog…The recall of the WASP (Walk Away Specimen Process) instrument was initiated because Copan Italia SpA has… | Copan Italia | 08/09/2013Terminated |
| Z-1999-2009 | 300 Microliter CO-RE Tips for use with Microlab STAR, manufactured by Hamilton Company…Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense… | Hamilton Co | 04/09/2009Terminated |
| Z-1203-2009 | 300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number…Some tips may be occluded and are unable to aspirate or dispense liquid. | Hamilton Co | 12/01/2008Terminated |
| Z-0718-2008 | Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24). Product Code: 866.2500; Part…Incorrectly labeled-- Product has the wrong barcode labeling. The barcode error will not influence the… | Hamilton Co | 06/25/2007Terminated |