The following data is part of a premarket notification filed by Pdz-europa Ltd. with the FDA for Abca Gas Isotope Ratio Mass Spectrometer Systems.
| Device ID | K992163 |
| 510k Number | K992163 |
| Device Name: | ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS |
| Classification | Mass Spectrometer, Clinical Use |
| Applicant | PDZ-EUROPA LTD. 325COLLEGE RD. Concord, MA 01742 |
| Contact | Robert F Martin |
| Correspondent | Robert F Martin PDZ-EUROPA LTD. 325COLLEGE RD. Concord, MA 01742 |
| Product Code | DOP |
| CFR Regulation Number | 862.2860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-25 |
| Decision Date | 1999-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05061024690009 | K992163 | 000 |