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 Visual, Pregnancy Hcg, Prescription Use
510(k) Number K884880
Device Name PREGNAGEN(TM)
Applicant
Biogenex Laboratories
4600 Norris Canyon Rd.
San Ramon,  CA  94583
Applicant Contact KRISHAN L KALRA,PHD
Correspondent
Biogenex Laboratories
4600 Norris Canyon Rd.
San Ramon,  CA  94583
Correspondent Contact KRISHAN L KALRA,PHD
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/21/1988
Decision Date 01/13/1989
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
-
-