Cleared Traditional

POTASSIUM QVET

K943026 · Prisma Systems · Chemistry
Dec 1994
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K943026 is an FDA 510(k) clearance for the POTASSIUM QVET, a Tetraphenyl Borate, Colorimetry, Potassium (Class II — Special Controls, product code CEJ), submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 9, 1994, 165 days after receiving the submission on June 27, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K943026 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1994
Decision Date December 09, 1994
Days to Decision 165 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEJ — Tetraphenyl Borate, Colorimetry, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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