K844498 is an FDA 510(k) clearance for the SANDARE ALKALINE PHOSPHATASE PROCEDURE. This device is classified as a Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes (Class II - Special Controls, product code CIO).
Submitted by Sandare Chemical Co., Inc. (Desoto, US). The FDA issued a Cleared decision on December 10, 1984, 20 days after receiving the submission on November 20, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1050.
| 510(k) Number | K844498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 1984 |
| Decision Date | December 10, 1984 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIO — Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1050 |