Cleared Traditional

CSF/URINE TOTAL PROTEIN

K961864 · Teco Diagnostics · Chemistry
Oct 1996
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K961864 is an FDA 510(k) clearance for the CSF/URINE TOTAL PROTEIN, a Biuret (colorimetric), Total Protein (Class II — Special Controls, product code CEK), submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on October 24, 1996, 163 days after receiving the submission on May 14, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K961864 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1996
Decision Date October 24, 1996
Days to Decision 163 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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