FDA 510(k) Application Details - K961276

Device Classification Name	Radioimmunoassay, Gastrin   More FDA Info for this Device
510(K) Number	K961276
Device Name	Radioimmunoassay, Gastrin
Applicant	BIOSYN LTD. 10, MALONE RD. BELFAST IE Other 510(k) Applications for this Company
Contact	CONOR D MCGURK Other 510(k) Applications for this Contact
Regulation Number	862.1325   More FDA Info for this Regulation Number
Classification Product Code	CGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/1996
Decision Date	05/30/1996
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