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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K982591
Device Name DADE TRU-LIQUID CARDIAC CONTROL
Applicant
Dade Behring, Inc.
1851 Delaware Pkwy.
Miami,  FL  33125
Applicant Contact JOHN CRAMER
Correspondent
Dade Behring, Inc.
1851 Delaware Pkwy.
Miami,  FL  33125
Correspondent Contact JOHN CRAMER
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/24/1998
Decision Date 08/05/1998
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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