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FDA 510(k) Application Details - K040920
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K040920
Device Name
Catalytic Methods, Amylase
Applicant
TECO DIAGNOSTICS
1268 NORTH LAKEVIEW AVE.
ANAHEIM, CA 92807 US
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Contact
JIAN VAECHES
Other 510(k) Applications for this Contact
Regulation Number
862.1070
More FDA Info for this Regulation Number
Classification Product Code
JFJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/08/2004
Decision Date
05/10/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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