Cleared Traditional

ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)

K973369 · Roche Diagnostic Systems, Inc. · Chemistry
Nov 1997
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K973369 is an FDA 510(k) clearance for the ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM), a Ldl & Vldl Precipitation, Hdl (Class I — General Controls, product code LBR), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on November 21, 1997, 74 days after receiving the submission on September 8, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K973369 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1997
Decision Date November 21, 1997
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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