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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 K984067
Device Name STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
Applicant
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number862.1215
Classification Product Code
JHX  
Date Received11/16/1998
Decision Date 01/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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