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 Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K925189
Device Name PREGNAGEN 1-STEP PREGNANCY TEST
Applicant
Biogenex Laboratories
10366 B Roselle St.
San Diego,  CA  92121
Applicant Contact SHUNG-HO CHANG
Correspondent
Biogenex Laboratories
10366 B Roselle St.
San Diego,  CA  92121
Correspondent Contact SHUNG-HO CHANG
Regulation Number862.1155
Classification Product Code
LCX  
Date Received10/13/1992
Decision Date 01/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-