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510(k) K041596

ARCHITECT STAT CK-MB IMMUNOASSAY by Fisher Diagnostics — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2004
Date Received
June 14, 2004
Clearance Type
Traditional
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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