Cleared Traditional

LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40

K041927 · Diagnostic Chemicals , Ltd. · Chemistry
Nov 2004
Decision
127d
Days
Class 1
Risk

About This 510(k) Submission

K041927 is an FDA 510(k) clearance for the LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on November 23, 2004, 127 days after receiving the submission on July 19, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K041927 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2004
Decision Date November 23, 2004
Days to Decision 127 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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