Cleared Traditional

ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN

K982551 · Roche Diagnostic Systems, Inc. · Toxicology
Aug 1998
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K982551 is an FDA 510(k) clearance for the ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 18, 1998, 27 days after receiving the submission on July 22, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K982551 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1998
Decision Date August 18, 1998
Days to Decision 27 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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