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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K984093
Device Name STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
Applicant
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714
Applicant Contact REBECCA S AYASH
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714
Correspondent Contact REBECCA S AYASH
Regulation Number862.1215
Classification Product Code
MMI  
Date Received11/16/1998
Decision Date 12/14/1998
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
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