FDA 510(k) Application Details - K010050

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K010050
Device Name	Acid, Folic, Radioimmunoassay
Applicant	BAYER DIAGNOSTICS CORP. 63 NORTH ST. MEDFIELD, MA 02052 US Other 510(k) Applications for this Company
Contact	THOMAS F FLYNN Other 510(k) Applications for this Contact
Regulation Number	862.1295   More FDA Info for this Regulation Number
Classification Product Code	CGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2001
Decision Date	02/05/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review