FDA 510(k) Application Details - K081150

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K081150
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	TURKLAB MEDICAL DEVICES INC 10040 SK. ATATURK ORGANIZE SANAYI BOLGESI CIGLI IZMIR, 35100 TR Other 510(k) Applications for this Company
Contact	HILDA CIL 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	04/23/2008
Decision Date	06/16/2009
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