FDA 510(k) Application Details - K052645

Device Classification Name	Antistreptolysin - Titer/Streptolysin O Reagent   More FDA Info for this Device
510(K) Number	K052645
Device Name	Antistreptolysin - Titer/Streptolysin O Reagent
Applicant	ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. ROCHESTER, NY 14626-5101 US Other 510(k) Applications for this Company
Contact	MICHAEL M BYRNE Other 510(k) Applications for this Contact
Regulation Number	866.3720   More FDA Info for this Regulation Number
Classification Product Code	GTQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2005
Decision Date	12/14/2005
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