The following data is part of a premarket notification filed by Pantex, Div. Bio-analysis, Inc. with the FDA for Pantex Direct Testosterone Coated Tube Radioimmuno.
Device ID | K853865 |
510k Number | K853865 |
Device Name: | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO |
Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
Applicant | PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
Contact | Neil Y Chiamori |
Correspondent | Neil Y Chiamori PANTEX, DIV. BIO-ANALYSIS, INC. 1737 21ST ST. Santa Monica, CA 90404 |
Product Code | CDZ |
CFR Regulation Number | 862.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-17 |
Decision Date | 1985-10-15 |