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 |