Cleared Traditional

URINARY/CEREBROSPINAL FLUID PROTEIN

K934841 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Apr 1994
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K934841 is an FDA 510(k) clearance for the URINARY/CEREBROSPINAL FLUID PROTEIN, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 6, 1994, 180 days after receiving the submission on October 8, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K934841 FDA.gov
FDA Decision Cleared SESE
Date Received October 08, 1993
Decision Date April 06, 1994
Days to Decision 180 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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