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FDA 510(k) Application Details - K070064
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K070064
Device Name
Catalytic Methods, Amylase
Applicant
Thermo Fisher Scientific
189-199 BROWNS RD.
NOBLE PARK, VICTORIA 3174 AU
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Contact
MELITA LAMBIRIS
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
01/05/2007
Decision Date
05/22/2007
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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