Cleared Traditional

AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR

K981978 · Pointe Scientific, Inc., · Chemistry
Jul 1998
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K981978 is an FDA 510(k) clearance for the AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on July 22, 1998, 47 days after receiving the submission on June 5, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K981978 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1998
Decision Date July 22, 1998
Days to Decision 47 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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