Submission Details
| 510(k) Number | K841891 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 07, 1984 |
| Decision Date | July 09, 1984 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K841891 is an FDA 510(k) clearance for the VARIAN 3300 & 3400 GAS CHROMATOGRAPHS, a Chromatography(gas), Clinical Use (Class I — General Controls, product code KZQ), submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 9, 1984, 63 days after receiving the submission on May 7, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2250.
| 510(k) Number | K841891 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 07, 1984 |
| Decision Date | July 09, 1984 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KZQ — Chromatography(gas), Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2250 |