FDA 510(k) Application Details - K971591

Device Classification Name	Reagent, Rickettsia Serological   More FDA Info for this Device
510(K) Number	K971591
Device Name	Reagent, Rickettsia Serological
Applicant	DAVID C. BISHOP, PH.D. 605 DILWORTH RD. DOWNINGTOWN, PA 19335 US Other 510(k) Applications for this Company
Contact	DAVID C BISHOP Other 510(k) Applications for this Contact
Regulation Number	866.3500   More FDA Info for this Regulation Number
Classification Product Code	LSQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/1997
Decision Date	03/13/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review