Cleared Traditional

LIQUID LDH-L REAGENT SET

K973589 · Pointe Scientific, Inc., · Chemistry
Oct 1997
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K973589 is an FDA 510(k) clearance for the LIQUID LDH-L REAGENT SET, a Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (Class II — Special Controls, product code CFJ), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on October 8, 1997, 16 days after receiving the submission on September 22, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1440.

Submission Details

510(k) Number K973589 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1997
Decision Date October 08, 1997
Days to Decision 16 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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