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FDA 510(k) Application Details - K062128
Device Classification Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
More FDA Info for this Device
510(K) Number
K062128
Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BLDG 500;M.S.514
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
LORRAINE H PIESTRAK
Other 510(k) Applications for this Contact
Regulation Number
862.1215
More FDA Info for this Regulation Number
Classification Product Code
JHS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/26/2006
Decision Date
08/21/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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