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510(k) K760345

TEST, LACTATE DEHYDROGENASE by Princeton Biomedix — Product Code CFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1976
Date Received
August 2, 1976
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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