The following data is part of a premarket notification filed by Europa Scientific, Ltd. with the FDA for Abca-nt Gas Isotope Ratio Mass Spectrometer System.
| Device ID | K974322 |
| 510k Number | K974322 |
| Device Name: | ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM |
| Classification | Mass Spectrometer, Clinical Use |
| Applicant | EUROPA SCIENTIFIC, LTD. 325 COLLEGE RD. Concord, MA 01742 |
| Contact | Robert F Martin |
| Correspondent | Robert F Martin EUROPA SCIENTIFIC, LTD. 325 COLLEGE RD. Concord, MA 01742 |
| Product Code | DOP |
| CFR Regulation Number | 862.2860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-17 |
| Decision Date | 1997-12-16 |
| Summary: | summary |