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 K991369
Device Name ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY
Applicant
GERMAINE LABORATORIES, INC.
4203 GARDENDALE CENTER, #230
SAN ANTONIO,  TX  78229
Applicant Contact MARTIN O'CONNOR
Correspondent
GERMAINE LABORATORIES, INC.
4203 GARDENDALE CENTER, #230
SAN ANTONIO,  TX  78229
Correspondent Contact MARTIN O'CONNOR
Regulation Number862.1155
Classification Product Code
LCX  
Date Received04/20/1999
Decision Date 05/10/1999
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
-
-