K913091 is an FDA 510(k) clearance for the BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY. This device is classified as a Radioassay, Angiotensin Converting Enzyme (Class II - Special Controls, product code KQN).
Submitted by American Laboratory Products Co., Ltd. (Windham, US). The FDA issued a Cleared decision on August 26, 1991, 45 days after receiving the submission on July 12, 1991.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1090.
| 510(k) Number | K913091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 1991 |
| Decision Date | August 26, 1991 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | KQN — Radioassay, Angiotensin Converting Enzyme |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1090 |