FDA 510(k) Application Details - K965169

Device Classification Name	Enzyme Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K965169
Device Name	Enzyme Controls (Assayed And Unassayed)
Applicant	SPECIALIZED ASSAYS, INC. P.O. BOX 60 PIPERSVILLE, PA 18947 US Other 510(k) Applications for this Company
Contact	RICHARD A KAUFMAN Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/1996
Decision Date	02/06/1997
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