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FDA 510(k) Application Details - K980013
Device Classification Name
Saccharogenic, Amylase
More FDA Info for this Device
510(K) Number
K980013
Device Name
Saccharogenic, Amylase
Applicant
AC BIOCHEMICALS, INC.
17955 SKY PARK CIRCLE, SUITE J
IRVINE, CA 92614 US
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Contact
CHARLES C ALLAIN
Other 510(k) Applications for this Contact
Regulation Number
862.1070
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Classification Product Code
CIJ
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More FDA Info for this Product Code
Date Received
01/02/1998
Decision Date
02/04/1998
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
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