Cleared Traditional

BIURET REAGENT & TOTAL PROTEIN BLANK SOL

K802161 · Panmed, Inc. · Chemistry
Oct 1980
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K802161 is an FDA 510(k) clearance for the BIURET REAGENT & TOTAL PROTEIN BLANK SOL, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980, 32 days after receiving the submission on September 8, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K802161 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1980
Decision Date October 10, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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