Cleared Traditional

POTASSIUM REAGENT SET

K813608 · Diagnostic Specialties · Chemistry
Jan 1982
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K813608 is an FDA 510(k) clearance for the POTASSIUM REAGENT SET, a Tetraphenyl Borate, Colorimetry, Potassium (Class II — Special Controls, product code CEJ), submitted by Diagnostic Specialties (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982, 24 days after receiving the submission on December 29, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K813608 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1981
Decision Date January 22, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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