FDA 510(k) Application Details - K991866

Device Classification Name	Diazo Colorimetry, Bilirubin   More FDA Info for this Device
510(K) Number	K991866
Device Name	Diazo Colorimetry, Bilirubin
Applicant	A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 BRIDGEPORT, CT US Other 510(k) Applications for this Company
Contact	LUIS P LEON Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	CIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/1999
Decision Date	08/02/1999
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