Cleared Traditional

CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES

K882488 · Canyon Diagnostics, Inc. · Chemistry
Aug 1988
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K882488 is an FDA 510(k) clearance for the CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES, a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on August 15, 1988, 60 days after receiving the submission on June 16, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K882488 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1988
Decision Date August 15, 1988
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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