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FDA 510(k) Application Details - K080823
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K080823
Device Name
Catalytic Methods, Amylase
Applicant
MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD, MA 01730 US
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Contact
Photios Makris
Other 510(k) Applications for this Contact
Regulation Number
862.1070
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Classification Product Code
JFJ
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More FDA Info for this Product Code
Date Received
03/24/2008
Decision Date
11/17/2008
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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