FDA 510(k) Application Details - K981207

Device Classification Name	Test, Luteinizing Hormone (Lh), Over The Counter   More FDA Info for this Device
510(K) Number	K981207
Device Name	Test, Luteinizing Hormone (Lh), Over The Counter
Applicant	UNIPATH LTD. PRIORY BUSINESS PARK BEDFORD MK44 3UP GB Other 510(k) Applications for this Company
Contact	Louise Roberts Other 510(k) Applications for this Contact
Regulation Number	862.1485   More FDA Info for this Regulation Number
Classification Product Code	NGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/02/1998
Decision Date	10/28/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review