K904761 is an FDA 510(k) clearance for the P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT. This device is classified as a Volumetric/manometric, Carbon-dioxide (Class II - Special Controls, product code CIE).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on November 20, 1990, 32 days after receiving the submission on October 19, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.
| 510(k) Number | K904761 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1990 |
| Decision Date | November 20, 1990 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIE — Volumetric/manometric, Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1160 |