FDA 510(k) Application Details - K972576

Device Classification Name	Gram Positive Identification Panel   More FDA Info for this Device
510(K) Number	K972576
Device Name	Gram Positive Identification Panel
Applicant	ACCUMED INTL., INC. 29299 CLEMENS RD. SUITE 1K WESTLAKE, OH 44145 US Other 510(k) Applications for this Company
Contact	CINDY KNAPP Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	LQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/1997
Decision Date	01/22/1998
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