Cleared Traditional

ROCHE COBAS IBTEGRA REAGENT CASSETTES

K964457 · Roche Diagnostic Systems, Inc. · Chemistry
Jan 1997
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K964457 is an FDA 510(k) clearance for the ROCHE COBAS IBTEGRA REAGENT CASSETTES, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 13, 1997, 68 days after receiving the submission on November 6, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K964457 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1996
Decision Date January 13, 1997
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JQB — Kinetic Method, Gamma-glutamyl Transpeptidase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1360

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