Submission Details
| 510(k) Number | K992163 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 25, 1999 |
| Decision Date | July 13, 1999 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Special
ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
Jul 1999
Decision
18d
Days
Class 1
Risk
About This 510(k) Submission
K992163 is an FDA 510(k) clearance for the ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS, a Mass Spectrometer, Clinical Use (Class I — General Controls, product code DOP), submitted by Pdz-Europa , Ltd. (Concord, US). The FDA issued a Cleared decision on July 13, 1999, 18 days after receiving the submission on June 25, 1999. 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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