K771507 is an FDA 510(k) clearance for the MULTISTAT III BICARBONATE TEST. This device is classified as a Enzymatic, Carbon-dioxide (Class II - Special Controls, product code KHS).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977, 81 days after receiving the submission on August 5, 1977.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K771507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1977 |
| Decision Date | October 25, 1977 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |