ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
FDA 510(k) clearance K974322 · decided 1997-12-16
Clearance details
- K-number
- K974322
- Device name
- ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
- Applicant
- Europa Scientific, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-17
- Decision date
- 1997-12-16
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- DOP
- Device class
- 1
- Regulation number
- 862.2860
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Concord, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (K992163) | Pdz-Europa , Ltd. | 1999-07-13 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.