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510(k) K963251

CIBA CORNING ACS;180 DPD ASSAY by Ciba Corning Diagnostics Corp. — Product Code JMM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1996
Date Received
August 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Column Chromatography & Color Development, Hydroxyproline
Device Class
Class I
Regulation Number
862.1400
Review Panel
CH
Submission Type

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  • K962126 — ACS CKMB II IMMUNOASSAY (June 21, 1996)
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