DOP — Mass Spectrometer, Clinical Use Class I
FDA product code DOP covers "Mass Spectrometer, Clinical Use", a Class I medical device regulated under 21 CFR 862.2860. Submissions are reviewed by the Clinical Chemistry panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DOP
- Device Class
- Class I
- Regulation Number
- 862.2860
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K992163 | pdz-europa | ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS | July 13, 1999 |
| K974322 | europa scientific | ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM | December 16, 1997 |
| K880418 | finnigan | INCOS 50 MASS SPECTROMETER | May 31, 1988 |
| K880090 | finnigan | ION TRAP DETECTOR | March 15, 1988 |
| K880089 | finnigan | FINNIGAN MAT TSQ-70 | February 11, 1988 |
| K872464 | perkin-elmer | ION TRAP DETECTOR (ITD) | August 11, 1987 |
| K854076 | airspec | MGA 2000 GAS ANALYSER | December 11, 1985 |
| K810938 | allied healthcare products | MASS SPECTROMETER-MEDSPECT II | April 23, 1981 |
| K770994 | instrumentation laboratory | FURNACE AUTOSAMPLER, MODEL 155 | August 22, 1977 |
| K770637 | perkin-elmer | MERCURY/HYDRIDE SYSTEM MHS-1 | June 23, 1977 |