K872122 is an FDA 510(k) clearance for the 8000 SERIES GAS CHROMATOGRAPHS. This device is classified as a Chromatography(gas), Clinical Use (Class I — General Controls, product code KZQ).
Submitted by The Perkin-Elmer Corp.. The FDA issued a Cleared decision on June 17, 1987, 15 days after receiving the submission on June 2, 1987.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2250.
| 510(k) Number | K872122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1987 |
| Decision Date | June 17, 1987 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KZQ — Chromatography(gas), Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2250 |