FDA 510(k) Application Details - K012243

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K012243
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	HEMATRONIX, INC. 524 STONE RD. SUITE A BENICIA, CA 94510 US Other 510(k) Applications for this Company
Contact	JAMES S AFRANKO Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/17/2001
Decision Date	08/20/2001
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