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510(k) K760347

SET, TRINDER GLUCOSE by Princeton Biomedix — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1976
Date Received
August 2, 1976
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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  • K761315 — ALKALINE PHOSPHATASE (ALP)/PNPP (February 24, 1977)

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