Cleared Traditional

COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT

K982848 · Roche Diagnostic Systems, Inc. · Chemistry
Oct 1998
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K982848 is an FDA 510(k) clearance for the COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT, a System, Test, Low Density, Lipoprotein (Class I — General Controls, product code MRR), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 1, 1998, 50 days after receiving the submission on August 12, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K982848 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1998
Decision Date October 01, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRR — System, Test, Low Density, Lipoprotein
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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