K934751 is an FDA 510(k) clearance for the ACTIVE ANDROSTANEDIOL GLUCURONIDE. This device is classified as a Radioimmunoassay, Androstenedione (Class I - General Controls, product code CIZ).
Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on January 10, 1994, 98 days after receiving the submission on October 4, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1075.
| 510(k) Number | K934751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1993 |
| Decision Date | January 10, 1994 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CIZ — Radioimmunoassay, Androstenedione |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1075 |