K041657 is an FDA 510(k) clearance for the THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT. This device is classified as a Radioassay, Angiotensin Converting Enzyme (Class II - Special Controls, product code KQN).
Submitted by Thermo Electron Corporation (Louisville, US). The FDA issued a Cleared decision on August 30, 2004, 73 days after receiving the submission on June 18, 2004.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1090.
| 510(k) Number | K041657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2004 |
| Decision Date | August 30, 2004 |
| Days to Decision | 73 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 |