Cleared Traditional

HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)

K932766 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry
Dec 1993
Decision
185d
Days
Class 1
Risk

About This 510(k) Submission

K932766 is an FDA 510(k) clearance for the HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM), a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Diagnostic Chemicals, Ltd. (Usa) (Charlottestown,Pei,Canada, CA). The FDA issued a Cleared decision on December 10, 1993, 185 days after receiving the submission on June 8, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K932766 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 1993
Decision Date December 10, 1993
Days to Decision 185 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LBR — Ldl & Vldl Precipitation, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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