FDA 510(k) Application Details - K963911

Device Classification Name	Radioimmunoassay, Immunoreactive Insulin   More FDA Info for this Device
510(K) Number	K963911
Device Name	Radioimmunoassay, Immunoreactive Insulin
Applicant	AMERICAN LABORATORY PRODUCTS CO., LTD. 87 INDIAN ROCK RD. WINDHAM, NH 03087 US Other 510(k) Applications for this Company
Contact	RICHARD CONLEY Other 510(k) Applications for this Contact
Regulation Number	862.1405   More FDA Info for this Regulation Number
Classification Product Code	CFP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/1996
Decision Date	11/01/1996
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