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, Estriol
510(k) Number K801424
Device Name ESTRIOL RIA KIT FOR USE WITH GAMMAFLO
Applicant
Squibb & Sons, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Squibb & Sons, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1265
Classification Product Code
CGI  
Date Received06/17/1980
Decision Date 07/21/1980
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
-
-