FDA 510(k) Application Details - K973860

Device Classification Name	Test, Luteinizing Hormone (Lh), Over The Counter   More FDA Info for this Device
510(K) Number	K973860
Device Name	Test, Luteinizing Hormone (Lh), Over The Counter
Applicant	CONCEPTION TECHNOLOGY, INC. 214 S. COLLEGE AVE. FT. COLLINS, CO 80524 US Other 510(k) Applications for this Company
Contact	TERRY R KNAPP, MD 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	10/09/1997
Decision Date	01/07/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review