Cleared Traditional

VITROS CHEMISTRY PRODUCTS UPRO SLIDES

K964960 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry
Feb 1997
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K964960 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS UPRO SLIDES, a Lowry (colorimetric), Total Protein (Class II — Special Controls, product code JGP), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 18, 1997, 69 days after receiving the submission on December 11, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K964960 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1996
Decision Date February 18, 1997
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JGP — Lowry (colorimetric), Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635

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