K981607 is an FDA 510(k) clearance for the ACTIVE RENIN IRMA MODEL NUMBER DSL-25100. This device is classified as a Radioimmunoassay, Angiotensin I And Renin (Class II - Special Controls, product code CIB).
Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on May 27, 1998, 22 days after receiving the submission on May 5, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1085.
| 510(k) Number | K981607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1998 |
| Decision Date | May 27, 1998 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIB — Radioimmunoassay, Angiotensin I And Renin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1085 |