Cleared Traditional

KING DIAGNOSTICS LDH TEST

K862306 · King Diagnostics, Inc. · Chemistry
Aug 1986
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K862306 is an FDA 510(k) clearance for the KING DIAGNOSTICS LDH TEST, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 19, 1986, 63 days after receiving the submission on June 17, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K862306 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1986
Decision Date August 19, 1986
Days to Decision 63 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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