Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Radioimmunoassay, Angiotensin I And Renin
510(k) Number K820616
Device Name ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY
Applicant
E. R. Squibb & Sons, Inc.
40 W 57th St.
New York,  NY  10019
Correspondent
E. R. Squibb & Sons, Inc.
40 W 57th St.
New York,  NY  10019
Regulation Number862.1085
Classification Product Code
CIB  
Date Received03/08/1982
Decision Date 03/26/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-