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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 K843774
Device Name RAICHEM X-HBDH REAGENT
Applicant
Reagents Applications, Inc.
7605 Convoy Ct.
San Diego,  CA  92111
Applicant Contact GIOVANNI BUCOLO
Correspondent
Reagents Applications, Inc.
7605 Convoy Ct.
San Diego,  CA  92111
Correspondent Contact GIOVANNI BUCOLO
Regulation Number862.1380
Classification Product Code
JMK  
Date Received09/25/1984
Decision Date 10/31/1984
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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