Submission Details
| 510(k) Number | K974322 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 1997 |
| Decision Date | December 16, 1997 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM
Dec 1997
Decision
29d
Days
Class 1
Risk
About This 510(k) Submission
K974322 is an FDA 510(k) clearance for the ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM, a Mass Spectrometer, Clinical Use (Class I — General Controls, product code DOP), submitted by Europa Scientific, Ltd. (Concord, US). The FDA issued a Cleared decision on December 16, 1997, 29 days after receiving the submission on November 17, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2860.
Device Classification
| Product Code | DOP — Mass Spectrometer, Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2860 |
Manufacturer
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