Cleared Traditional

LACTATE DEHYDROGENASE (LD)

K935175 · Em Diagnostic Systems, Inc. · Chemistry
Dec 1993
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K935175 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE (LD), a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 16, 1993, 50 days after receiving the submission on October 27, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K935175 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1993
Decision Date December 16, 1993
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFJ — Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1440

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