Cleared Traditional

LDH S.C.E.

K863068 · J. D. Assoc. · Chemistry
Dec 1986
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K863068 is an FDA 510(k) clearance for the LDH S.C.E., a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 10, 1986, 120 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K863068 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date December 10, 1986
Days to Decision 120 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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