Abca Gas Isotope Ratio Mass Spectrometer Systems
FDA 510(k) K992163 · Pdz-Europa , Ltd.
510(k) numberK992163
Submission
- Device name
- Abca Gas Isotope Ratio Mass Spectrometer Systems
- Applicant
- Pdz-Europa , Ltd.
Concord, MA, US - Received
- June 25, 1999
- Decision date
- July 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DOP – Mass Spectrometer, Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2860
- Specialty
- Clinical Chemistry
Other 510(k)s with product code DOP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974322 | Abca-Nt Gas Isotope Ratio Mass Spectrometer SystemDOP · Traditional | Europa Scientific, Ltd. | 12/16/1997SE |
| K880418 | Incos 50 Mass SpectrometerDOP · Traditional | Finnigan Corp. | 05/31/1988SE |
| K880090 | Ion Trap DetectorDOP · Traditional | Finnigan Corp. | 03/15/1988SE |
| K880089 | Finnigan Mat TSQ-70DOP · Traditional | Finnigan Corp. | 02/11/1988SE |
| K872464 | Ion Trap Detector (Itd)DOP · Traditional | The Perkin-Elmer Corp. | 08/11/1987SE |
| K854076 | Mga 2000 Gas AnalyserDOP · Traditional | Airspec , Ltd. | 12/11/1985SE |
| K810938 | Mass Spectrometer-Medspect IIDOP · Traditional | Allied Healthcare Products, Inc. | 04/23/1981SE |
| K770994 | Furnace Autosampler, Model 155DOP · Traditional | Instrumentation Laboratory CO | 08/22/1977SE |
| K770637 | Mercury/Hydride System MHS-1DOP · Traditional | The Perkin-Elmer Corp. | 06/23/1977SE |
Questions and answers
When was Abca Gas Isotope Ratio Mass Spectrometer Systems cleared by the FDA?
Abca Gas Isotope Ratio Mass Spectrometer Systems (K992163) received a 510(k) decision of Substantially Equivalent on July 13, 1999, 18 days after the submission was received.
What is the product code of K992163?
The FDA product code is DOP – Mass Spectrometer, Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2860.