Cleared Traditional

BICARBONATE REAGENTS PRODUCT #7713 & #7714

K900420 · American Research Products Co. · Chemistry
Mar 1990
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K900420 is an FDA 510(k) clearance for the BICARBONATE REAGENTS PRODUCT #7713 & #7714, a Ph Rate Measurement, Carbon-dioxide (Class II — Special Controls, product code JFL), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on March 1, 1990, 30 days after receiving the submission on January 30, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K900420 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1990
Decision Date March 01, 1990
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JFL — Ph Rate Measurement, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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