The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Gamma Coat Assay Testosterone Radioimmunoassay Kit.
| Device ID | K915570 |
| 510k Number | K915570 |
| Device Name: | GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | Ellen Best |
| Correspondent | Ellen Best INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-12 |
| Decision Date | 1992-01-27 |