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 K993317
Device Name ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
Applicant
ACON Laboratories, Inc.
11175 Flintkote Ave., #F
San Diego,  CA  92121
Applicant Contact NORA C.R. YORK
Correspondent
ACON Laboratories, Inc.
11175 Flintkote Ave., #F
San Diego,  CA  92121
Correspondent Contact NORA C.R. YORK
Regulation Number862.1155
Classification Product Code
JHI  
Date Received10/04/1999
Decision Date 12/01/1999
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
Recalls CDRH Recalls
-
-