The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for St Aia-pack Shbg, St Aia-pack Shbg Calibrator Set.
| Device ID | K143075 |
| 510k Number | K143075 |
| Device Name: | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Contact | Robert L Wick |
| Correspondent | Robert L Wick TOSOH BIOSCIENCE, INC. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-27 |
| Decision Date | 2015-07-02 |
| Summary: | summary |