FDA 510(k) Application Details - K954994

Device Classification Name	Antigens, Nontreponemal, All   More FDA Info for this Device
510(K) Number	K954994
Device Name	Antigens, Nontreponemal, All
Applicant	GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 COLUMBIA, MD 21045 US Other 510(k) Applications for this Company
Contact	KATHRYN B POWERS Other 510(k) Applications for this Contact
Regulation Number	866.3820   More FDA Info for this Regulation Number
Classification Product Code	GMQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/1995
Decision Date	10/18/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review