Home / 510(k) Clearances / K051650

510(k) K051650

STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. by Dade Behring, Inc. — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2005
Date Received
June 21, 2005
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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