Cleared Traditional

K874848 - LACTATE DEHYDROGENASE LDH-L
(FDA 510(k) Clearance)

K874848 · Tech-Co, Inc. · Chemistry
Dec 1987
Decision
24d
Days
Class 2
Risk

K874848 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE LDH-L, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on December 18, 1987, 24 days after receiving the submission on November 24, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K874848 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1987
Decision Date December 18, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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