The Perkin-Elmer Corp.
Medical device manufacturer in Waltham, MA.
62510(k) clearances
0PMA approvals
2recalls
Device types
- JXR Atomic Absorption Spectrophotometer… 17
- JJQ Colorimeter, Photometer, Spectrophotometer… 5
- KHO Fluorometer, For Clinical Use 5
- KZQ Chromatography(Gas), Clinical Use 5
- KZR Chromatography (Liquid, Gel), Clinical Use 5
- LDM Instrumentation, High Pressure Liquid… 5
- KIE Apparatus, High Pressure Liquid… 3
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 3
- DOP Mass Spectrometer, Clinical Use 2
- JRI Cuvette, Thermostated 1
- DPH Mercury, Atomic Absorption 1
- BXP Transducer, Gas Flow 1
- BZK Spirometer, Monitoring (W/Wo Alarm) 1
- BXW Calibrator, Volume, Gas 1
- CHL Electrode Measurement, Blood-Gases (Pco2… 1
- BZQ Monitor, Breathing Frequency 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K935666 | Perkin-Elmer Series 200 Liq Chromatographic PumpKIE · Traditional | 04/26/1994SE |
| K900828 | Perkin-Elmer Aa 3100 Atomic Absorption Spectro.JXR · Traditional | 04/09/1990SE |
| K884864 | Plasma 40 Induct. Coupled Plasma Emmission SpectroJJQ · Traditional | 02/10/1989SE |
| K884886 | Model 250 Liquid Chromotagraphy PumpLDM · Traditional | 02/02/1989SE |
| K872737 | Perkin-Elmer LC235 Diode Array Detector · Traditional | 09/18/1987SE |
| K872464 | Ion Trap Detector (Itd)DOP · Traditional | 08/11/1987SE |
| K871550 | PFI-20 Polarizing FluorimeterKHO · Traditional | 07/01/1987SE |
| K872122 | 8000 Series Gas ChromatographsKZQ · Traditional | 06/17/1987SE |
| K870661 | Lifewatch PlusBZQ · Traditional | 03/09/1987SE |
| K862605 | Modular Mass Spectrometer (M.S.)CCK · Traditional | 08/13/1986SE |
| K862178 | Isopure LC SystemLDM · Traditional | 07/14/1986SE |
| K860197 | Series 410 LC PumpKZR · Traditional | 03/17/1986SE |
| K853840 | Life Watch Respiratory MonitorCHL · Traditional | 12/09/1985SE |
| K843568 | Liquid Chromatograph 400KZR · Traditional | 11/20/1984SE |
| K842752 | Zeeman 3030 Atomic Absorpt SpectorphotJXR · Traditional | 08/22/1984SE |
| K842496 | ICP/6500 Inductively-Coupled Plasma-JXR · Traditional | 08/10/1984SE |
| K840977 | Liquid Chromatographic Detector LC-95KZR · Traditional | 04/19/1984SE |
| K832767 | Advantage #1700CCK · Traditional | 11/03/1983SE |
| K831387 | HS-100 Headspace Sampling AccessoryKZQ · Traditional | 08/24/1983SE |
| K831758 | Flow-Calibration ModuleBXW · Traditional | 07/19/1983SE |
| K830799 | Inductively-Coupled Plasma SpectrometerJXR · Traditional | 04/12/1983SE |
| K830147 | Sigma 300 Gas ChromatrographKZQ · Traditional | 02/07/1983SE |
| K821727 | Series 10 Liquid ChromotographLDM · Traditional | 06/22/1982SE |
| K821219 | Series 4 Liquid ChromatographLDM · Traditional | 05/28/1982SE |
| K820320 | Model 3030 Atomic Absorption Spectro-JXR · Traditional | 03/01/1982SE |
| K820283 | Sigma 2000 Gas ChromatographKZQ · Traditional | 02/23/1982SE |
| K810536 | ZEEMAN/5000 Graphite Furnace Atomic AbsbJXR · Traditional | 03/17/1981SE |
| K810304 | Model LC-85 UV DetectorLDM · Traditional | 02/25/1981SE |
| K800086 | RMS 111F Respiratory Monitoring SystemBZK · Traditional | 05/08/1980SE |
| K800087 | Ultrasonic FlowmeterBXP · Traditional | 03/19/1980SE |
| K792557 | Spectrophatometer Models 2280 & 2380AAJXR · Traditional | 01/16/1980SE |
| K792146 | Atomic Spectroscopy SystemJXR · Traditional | 11/30/1979SE |
| K791074 | Model MHS-20, Atomic Absorption AccessJXR · Traditional | 08/22/1979SE |
| K790795 | Model 4000, SpectrophotometerJXR · Traditional | 07/24/1979SE |
| K790111 | Atomizer, Furnace Model HGA-400JXR · Traditional | 04/04/1979SE |
| K790117 | Autosampler, Model AS-40JXR · Traditional | 03/19/1979SE |
| K790236 | Spectrophotometer Model 650-40KHO · Traditional | 03/15/1979SE |
| K790235 | Spectrophotometer Model 3000KHO · Traditional | 03/15/1979SE |
| K780680 | Unit, Spectra, Corrected, Differential · Traditional | 08/08/1978SE |
| K781010 | Mercury/Hydride Atomic Absorption AccessDPH · Traditional | 07/27/1978SE |
| K780342 | SpectrophotometersJXR · Traditional | 04/10/1978SE |
| K780129 | Atomizer, Furnace, GraphiteJXR · Traditional | 04/05/1978SE |
| K780242 | Spectrophotometer, Fluorescence M.650-10KHO · Traditional | 03/27/1978SE |
| K780333 | Gas Chromatography Head Space Samp. HS6 · Traditional | 03/09/1978SE |
| K780112 | Spectrophotometer, Model 5000JXR · Traditional | 01/30/1978SE |
| K771156 | Monitor, Liq. Chromatography LC-15 UVKIE · Traditional | 08/02/1977SE |
| K770640 | Graphite Atomizer, HGA-76B · Traditional | 06/24/1977SE |
| K770637 | Mercury/Hydride System MHS-1DOP · Traditional | 06/23/1977SE |
| K770721 | Monitors, Remote, RMS IIICCK · Traditional | 04/28/1977SE |
| K770526 | Digital ScannerJXR · Traditional | 04/08/1977SE |
| K770288 | Spectrophotometer, Model 597 IrJJQ · Traditional | 03/10/1977SE |
| K770278 | Spectrophotometers, Infrared Models X99JJQ · Traditional | 03/10/1977SE |
| K770255 | LC-65T Detector and OvenKZR · Traditional | 02/25/1977SE |
| K770254 | Chromatograph, Series 3, LiquidKZR · Traditional | 02/24/1977SE |
| K770025 | Gas Chromotographs, Sigma 1,2,3,4,&10KZQ · Traditional | 02/16/1977SE |
| K761317 | HGA-2200 Heated Graphite Atomizer · Traditional | 02/07/1977SE |
| K761316 | Absorption SpectrophotometersJXR · Traditional | 02/07/1977SE |
| K761219 | Series II Liquid ChromatographKIE · Traditional | 02/01/1977SE |
| K760769 | Temperature Regulated Five Cell HoldersJRI · Traditional | 11/30/1976SE |
| K760737 | Scattered Transmission AccessoryJJQ · Traditional | 11/24/1976SE |
| K760261 | Detector, Model LC-100 FluorescenceKHO · Traditional | 09/27/1976SE |
| K760112 | Spectrophotometer (Junior III)JJQ · Traditional | 07/16/1976SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1906-2009 | Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. The intended use of the…If Result Codes are used and if they are manually edited, they are correct unless the laboratory… | 01/15/2009Terminated |
| Z-1905-2009 | Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The…If Result Codes are used and if they are manually edited, they are correct unless the laboratory… | 01/15/2009Terminated |