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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K973869
Device Name TRACE REAGENT LINE FOR THE COBAS MIRA
Applicant
Trace America, Inc.
7260 NW 58th St.
Miami,  FL  33166
Applicant Contact David Johnston
Correspondent
Trace America, Inc.
7260 NW 58th St.
Miami,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1030
Classification Product Code
CKA  
Subsequent Product Codes
CDQ   CEK   CGX   CHH   CIG  
CIT   JFJ   JGY   JIY   JMO   KHS  
KNK  
Date Received09/24/1997
Decision Date 01/07/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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