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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 K961123
Device Name ALT INCORPORATING DST
Applicant
Trace Scientific , Ltd.
7260 NW 58th St.
Miami,  FL  33166
Applicant Contact David Johnston
Correspondent
Trace Scientific , Ltd.
7260 NW 58th St.
Miami,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1030
Classification Product Code
CKA  
Date Received03/21/1996
Decision Date 04/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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