Cleared Traditional

COBAS INTEGRA HDL-CHOLESTEROL DIRECT

K973284 · Roche Diagnostic Systems, Inc. · Chemistry
Dec 1997
Decision
107d
Days
Class 1
Risk

About This 510(k) Submission

K973284 is an FDA 510(k) clearance for the COBAS INTEGRA HDL-CHOLESTEROL DIRECT, a Enzymatic Esterase--oxidase, Cholesterol (Class I — General Controls, product code CHH), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 18, 1997, 107 days after receiving the submission on September 2, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1175.

Submission Details

510(k) Number K973284 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1997
Decision Date December 18, 1997
Days to Decision 107 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CHH — Enzymatic Esterase--oxidase, Cholesterol
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1175

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