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510(k) K993068

VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS by Ortho-Clinical Diagnostics — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1999
Date Received
September 13, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

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