The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Angiotensis I-squibb Radioimmunoassay.
Device ID | K820616 |
510k Number | K820616 |
Device Name: | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY |
Classification | Radioimmunoassay, Angiotensin I And Renin |
Applicant | E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York, NY 10019 |
Product Code | CIB |
CFR Regulation Number | 862.1085 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-08 |
Decision Date | 1982-03-26 |