Cleared Traditional

LIQUIZYME CHLORIDE REAGENT

K820411 · American Research Products Co. · Chemistry
Mar 1982
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K820411 is an FDA 510(k) clearance for the LIQUIZYME CHLORIDE REAGENT, a Coulometric, Chloride (Class II — Special Controls, product code JFS), submitted by American Research Products Co. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1982, 24 days after receiving the submission on February 12, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K820411 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1982
Decision Date March 08, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JFS — Coulometric, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170

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