DOP
10 FDA 510(k) clearances · Product code
63 daysmedian time to decision
120 days90th percentile
10clearances measured
FDA profile
- Official device name
- Mass Spectrometer, Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2860
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (K992163) | Pdz-Europa , Ltd. | 1999-07-13 |
| ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM (K974322) | Europa Scientific, Ltd. | 1997-12-16 |
| INCOS 50 MASS SPECTROMETER (K880418) | Finnigan Corp. | 1988-05-31 |
| ION TRAP DETECTOR (K880090) | Finnigan Corp. | 1988-03-15 |
| FINNIGAN MAT TSQ-70 (K880089) | Finnigan Corp. | 1988-02-11 |
| ION TRAP DETECTOR (ITD) (K872464) | The Perkin-Elmer Corp. | 1987-08-11 |
| MGA 2000 GAS ANALYSER (K854076) | Airspec , Ltd. | 1985-12-11 |
| MASS SPECTROMETER-MEDSPECT II (K810938) | Allied Healthcare Products, Inc. | 1981-04-23 |
| FURNACE AUTOSAMPLER, MODEL 155 (K770994) | Instrumentation Laboratory CO | 1977-08-22 |
| MERCURY/HYDRIDE SYSTEM MHS-1 (K770637) | The Perkin-Elmer Corp. | 1977-06-23 |
Track DOP automatically
Every clearance here is in the API, with alerts when new ones post.