Cleared Traditional

VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)

K965048 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry
Jan 1997
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K965048 is an FDA 510(k) clearance for the VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015), a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 27, 1997, 40 days after receiving the submission on December 18, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K965048 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1996
Decision Date January 27, 1997
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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