Cleared Traditional

REFLOTRON POTASSIUM TEST TABS

K904033 · Boehringer Mannheim Corp. · Chemistry
Nov 1990
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K904033 is an FDA 510(k) clearance for the REFLOTRON POTASSIUM TEST TABS, a Tetraphenyl Borate, Colorimetry, Potassium (Class II — Special Controls, product code CEJ), submitted by Boehringer Mannheim Corp. (Indianapolis,, US). The FDA issued a Cleared decision on November 6, 1990, 67 days after receiving the submission on August 31, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K904033 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1990
Decision Date November 06, 1990
Days to Decision 67 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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