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510(k) K871456

ULTRA-VIOLET GLUCOSE REAGENT KIT by Biochemical Trade, Inc. — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1987
Date Received
April 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

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  • K905588 — CREATINE KINASE UV REAGENT SET (January 17, 1991)

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