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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
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Contact
RAYMOND L PAVITT
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Regulation Number
864.7360
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Classification Product Code
JBL
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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
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