The following data is part of a premarket notification filed by Damon Corp. with the FDA for Liquisol Testosterone Radioimm. Test Kit.
Device ID | K802661 |
510k Number | K802661 |
Device Name: | LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT |
Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
Applicant | DAMON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CDZ |
CFR Regulation Number | 862.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-28 |
Decision Date | 1980-12-10 |