FDA 510(k) Application Details - K991246

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K991246
Device Name	Assay, Glycosylated Hemoglobin
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	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/1999
Decision Date	12/16/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review