Cleared Traditional

ROCHE COBAS READY HDL CHOLESTEROL REAGENT

K902935 · Roche Diagnostic Systems, Inc. · Chemistry
Sep 1990
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K902935 is an FDA 510(k) clearance for the ROCHE COBAS READY HDL CHOLESTEROL REAGENT, a Colorimetric Method, Lipoproteins (Class I — General Controls, product code JHM), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on September 27, 1990, 86 days after receiving the submission on July 3, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K902935 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1990
Decision Date September 27, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHM — Colorimetric Method, Lipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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