FDA 510(k) Application Details - K991369

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K991369
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	GERMAINE LABORATORIES, INC. 4203 GARDENDALE CENTER, #230 SAN ANTONIO, TX 78229 US Other 510(k) Applications for this Company
Contact	MARTIN O'CONNOR Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/1999
Decision Date	05/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review