K831075 is an FDA 510(k) clearance for the BLOOD GAS & FLAME PHOTOMETER INSTRU-. This device is classified as a Radioimmunoassay, Gastrin (Class I - General Controls, product code CGC).
Submitted by United Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1983, 79 days after receiving the submission on April 4, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1325.
| 510(k) Number | K831075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1983 |
| Decision Date | June 22, 1983 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CGC — Radioimmunoassay, Gastrin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1325 |