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FDA 510(k) Application Details - K972250
Device Classification Name
Catalytic Methods, Amylase
More FDA Info for this Device
510(K) Number
K972250
Device Name
Catalytic Methods, Amylase
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
BRANCHBURG TOWNSHIP
1080 U.S. HIGHWAY 202
SOMERVILLE, NJ 08876-3771 US
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Contact
MARIA FEIJOO
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
06/16/1997
Decision Date
08/12/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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