FDA 510(k) Application Details - K990957

Device Classification Name	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative   More FDA Info for this Device
510(K) Number	K990957
Device Name	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative
Applicant	ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. P.O. BOX 830 CLACKAMAS, OR 97015 US Other 510(k) Applications for this Company
Contact	RAYMOND L PAVITT Other 510(k) Applications for this Contact
Regulation Number	864.7360   More FDA Info for this Regulation Number
Classification Product Code	JBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/1999
Decision Date	05/11/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review