K851923 is an FDA 510(k) clearance for the AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE. This device is classified as a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I - General Controls, product code CKA).
Submitted by Amresco, Inc. (South Euclid, US). The FDA issued a Cleared decision on May 24, 1985, 22 days after receiving the submission on May 2, 1985.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K851923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1985 |
| Decision Date | May 24, 1985 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CKA — Nadh Oxidation/nad Reduction, Alt/sgpt |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1030 |