K820283 is an FDA 510(k) clearance for the SIGMA 2000 GAS CHROMATOGRAPH. This device is classified as a Chromatography(gas), Clinical Use (Class I - General Controls, product code KZQ).
Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1982, 21 days after receiving the submission on February 2, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2250.
| 510(k) Number | K820283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1982 |
| Decision Date | February 23, 1982 |
| Days to Decision | 21 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 |