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 K964633
Device Name ACCUPACK PREGNANCY TEST
Applicant
Genix Biotek, Inc.
11199 Sorrento Valley Rd., #J
San Diego,  CA  92121
Applicant Contact RICHARD WANG
Correspondent
Genix Biotek, Inc.
11199 Sorrento Valley Rd., #J
San Diego,  CA  92121
Correspondent Contact RICHARD WANG
Regulation Number862.1155
Classification Product Code
JHI  
Date Received11/19/1996
Decision Date 02/20/1997
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
-
-