510(k) K992163
- Device
- ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
- Applicant
- PDZ-EUROPA LTD.
- 510(k) number
- K992163
- Product code
- DOP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-07-13
- Date received
- 1999-06-25
- Regulation
- 862.2860
- Classification name
- Mass Spectrometer, Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT F MARTIN
- Address
- 325college Rd. Concord MA US 01742 01742
FDA Registration Numbers#
- 3043138885
- 3003423869
- 3009715051
- 3008336863
- 1218959
- 9614673
- 3043088937
- 8043909
- 3010962166
- 9616673
- 9610126
- 3009189893
- 3003809634
- 3001040364
- 3000221947
- 2916205
- 3010607747
- 3007386004
Source Documents#
Other 510(k) Records For Product Code DOP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974322 | ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM | Europa Scientific, Ltd. | 1997-12-16 |
| K880418 | INCOS 50 MASS SPECTROMETER | Finnigan Corp. | 1988-05-31 |
| K880090 | ION TRAP DETECTOR | Finnigan Corp. | 1988-03-15 |
| K880089 | FINNIGAN MAT TSQ-70 | Finnigan Corp. | 1988-02-11 |
| K872464 | ION TRAP DETECTOR (ITD) | The Perkin-Elmer Corp. | 1987-08-11 |
| K854076 | MGA 2000 GAS ANALYSER | Airspec , Ltd. | 1985-12-11 |
| K810938 | MASS SPECTROMETER-MEDSPECT II | Allied Healthcare Products, Inc. | 1981-04-23 |
| K770994 | FURNACE AUTOSAMPLER, MODEL 155 | Instrumentation Laboratory CO | 1977-08-22 |
| K770637 | MERCURY/HYDRIDE SYSTEM MHS-1 | The Perkin-Elmer Corp. | 1977-06-23 |
Legacy Summary#
summary
FDA Review#
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