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FDA 510(k) Application Details - K082226
Device Classification Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
More FDA Info for this Device
510(K) Number
K082226
Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL, NJ 07006 US
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Contact
DENNIS TASCHEK
Other 510(k) Applications for this Contact
Regulation Number
862.1215
More FDA Info for this Regulation Number
Classification Product Code
JHS
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More FDA Info for this Product Code
Date Received
08/07/2008
Decision Date
09/18/2008
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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