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510(k) K843774

RAICHEM X-HBDH REAGENT by Reagents Applications, Inc. — Product Code JMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
September 25, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
Device Class
Class I
Regulation Number
862.1380
Review Panel
CH
Submission Type

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