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 K962521
Device Name FACTPLUS ONE STEP PREGNANCY TEST
Applicant
DIRECT ACCESS DIAGNOSTICS
440 RT. 22 EAST
BRIDGEWATER,  NJ  08807
Applicant Contact MARYLOU PANICO
Correspondent
DIRECT ACCESS DIAGNOSTICS
440 RT. 22 EAST
BRIDGEWATER,  NJ  08807
Correspondent Contact MARYLOU PANICO
Regulation Number862.1155
Classification Product Code
LCX  
Date Received06/19/1996
Decision Date 07/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-