K143075 is an FDA 510(k) clearance for the ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set. This device is classified as a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I - General Controls, product code CDZ).
Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on July 2, 2015, 248 days after receiving the submission on October 27, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1680.
| 510(k) Number | K143075 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2014 |
| Decision Date | July 02, 2015 |
| Days to Decision | 248 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 |