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510(k) K946022

HICHEM LDH/L REAGENT KIT by Hichem Diagnostics — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1995
Date Received
December 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

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