FDA 510(k) Application Details - K961588

Device Classification Name	Photometric Method, Iron (Non-Heme)   More FDA Info for this Device
510(K) Number	K961588
Device Name	Photometric Method, Iron (Non-Heme)
Applicant	POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. LINCOLN PARK, MI 48146 US Other 510(k) Applications for this Company
Contact	WILLIAM F WALTERS Other 510(k) Applications for this Contact
Regulation Number	862.1410   More FDA Info for this Regulation Number
Classification Product Code	JIY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1996
Decision Date	11/18/1996
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