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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometric Method, Cpk Or Isoenzymes
510(k) Number K051650
Device Name STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG.500 M.S. 514; PO BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact PAMELA A JURGA
Correspondent
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY
BLDG.500 M.S. 514; PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact PAMELA A JURGA
Regulation Number862.1215
Classification Product Code
JHX  
Subsequent Product Codes
DDR   JIT   MMI  
Date Received06/21/2005
Decision Date 09/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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