Cleared Traditional

LIPOPRINT SYSTEM, LDL SUBFRACTIONS

K010337 · Quantimetrix Corp. · Chemistry
Jul 2001
Decision
170d
Days
Class 1
Risk

About This 510(k) Submission

K010337 is an FDA 510(k) clearance for the LIPOPRINT SYSTEM, LDL SUBFRACTIONS, a Electrophoretic Separation, Lipoproteins (Class I — General Controls, product code JHO), submitted by Quantimetrix Corp. (Redondo, US). The FDA issued a Cleared decision on July 25, 2001, 170 days after receiving the submission on February 5, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K010337 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2001
Decision Date July 25, 2001
Days to Decision 170 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHO — Electrophoretic Separation, Lipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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