FDA 510(k) Application Details - K023396

Device Classification Name	Saccharogenic, Amylase   More FDA Info for this Device
510(K) Number	K023396
Device Name	Saccharogenic, Amylase
Applicant	POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. LINCOLN PARK, MI 48146 US Other 510(k) Applications for this Company
Contact	RON JAMISON Other 510(k) Applications for this Contact
Regulation Number	862.1070   More FDA Info for this Regulation Number
Classification Product Code	CIJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2002
Decision Date	12/23/2002
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