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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 K861366
Device Name ALT-30, 60 AND 100
Applicant
Dimension Diagnostics
361 Windsor Place
St. Peters,  MO  63376
Applicant Contact CLYDE E HAM
Correspondent
Dimension Diagnostics
361 Windsor Place
St. Peters,  MO  63376
Correspondent Contact CLYDE E HAM
Regulation Number862.1030
Classification Product Code
CKA  
Date Received04/11/1986
Decision Date 06/25/1986
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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