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510(k) K813412

GLUCOSE ENZYME-COLOR REAGENT SET by Diagnostic Specialties — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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