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FDA 510(k) Application Details - K960246
Device Classification Name
Enzyme Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K960246
Device Name
Enzyme Controls (Assayed And Unassayed)
Applicant
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE, MA 02032 US
Other 510(k) Applications for this Company
Contact
RONALD D SCHAEFER
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/16/1996
Decision Date
04/23/1996
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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