Cleared Traditional

DUPONT DIMENSION TOTAL PROTEIN METHOD

K950920 · Dupont Medical Products · Chemistry
Aug 1995
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K950920 is an FDA 510(k) clearance for the DUPONT DIMENSION TOTAL PROTEIN METHOD, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on August 11, 1995, 163 days after receiving the submission on March 1, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K950920 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1995
Decision Date August 11, 1995
Days to Decision 163 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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