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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
510(k) Number K941427
Device Name SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH)
Applicant
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Applicant Contact K.C. CHEN
Correspondent
Teco Diagnostics
911 Via Rodeo
Placentia,  CA  92670
Correspondent Contact K.C. CHEN
Regulation Number862.1380
Classification Product Code
JMK  
Date Received03/24/1994
Decision Date 03/13/1995
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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