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FDA 510(k) Application Details - K962126
Device Classification Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
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510(K) Number
K962126
Device Name
Differential Rate Kinetic Method, Cpk Or Isoenzymes
Applicant
CIBA CORNING DIAGNOSTICS CORP.
17392 DAIMLER ST.
IRVINE, CA 92714 US
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Contact
THOMAS F FLYNN
Other 510(k) Applications for this Contact
Regulation Number
862.1215
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Classification Product Code
JHS
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More FDA Info for this Product Code
Date Received
06/03/1996
Decision Date
06/21/1996
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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