Cleared Special

MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

K013662 · Quantimetrix Corp. · Chemistry
Mar 2002
Decision
122d
Days
Class 1
Risk

About This 510(k) Submission

K013662 is an FDA 510(k) clearance for the MODIFICATION TO 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 March 8, 2002, 122 days after receiving the submission on November 6, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K013662 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2001
Decision Date March 08, 2002
Days to Decision 122 days
Submission Type Special
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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