Plasma 40 Induct. Coupled Plasma Emmission Spectro
FDA 510(k) K884864 · The Perkin-Elmer Corp.
510(k) numberK884864
Submission
- Device name
- Plasma 40 Induct. Coupled Plasma Emmission Spectro
- Applicant
- The Perkin-Elmer Corp.
Norwalk, CT, US - Received
- November 22, 1988
- Decision date
- February 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2300
- Specialty
- Clinical Chemistry
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| K980120 | Digene DML 2000 Microplate LuminometerJJQ · Traditional | Digene Corp. | 02/06/1998SE |
| K973938 | Alpha 4 LS Automated Microtiterplate Processor and ReaderJJQ · Traditional | Sfri, Inc. | 02/04/1998SE |
| K974762 | Stat TracksJJQ · Traditional | Awareness Technology, Inc. | 01/28/1998SE |
| K962113 | Anthos Phacts Version Microplate ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 11/05/1996SE |
| K961183 | Cbi 7520 ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 08/02/1996SE |
| K962166 | Origen AnalyzerJJQ · Traditional | Igen, Inc. | 07/31/1996SE |
| K955077 | Anthos 2010 ReaderJJQ · Traditional | Anthos Labtec, Inc. | 12/04/1995SE |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/19/1995SE |
More from Bio-Tek Instruments, Inc.
| 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 |
| 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 |
Questions and answers
When was Plasma 40 Induct. Coupled Plasma Emmission Spectro cleared by the FDA?
Plasma 40 Induct. Coupled Plasma Emmission Spectro (K884864) received a 510(k) decision of Substantially Equivalent on February 10, 1989, 80 days after the submission was received.
What is the product code of K884864?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.