FDA 510(k) Application Details - K024006

Device Classification Name	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening   More FDA Info for this Device
510(K) Number	K024006
Device Name	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
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	864.7360   More FDA Info for this Regulation Number
Classification Product Code	JBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2002
Decision Date	03/31/2003
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