K120009 is an FDA 510(k) clearance for the TESTOSTERONE TEST SYSTEM. This device is classified as a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I - General Controls, product code CDZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 11, 2012, 252 days after receiving the submission on January 3, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1680.
| 510(k) Number | K120009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2012 |
| Decision Date | September 11, 2012 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1680 |