Cleared Traditional

CHLORIDE/TCO2 ANALYZER REAGENTS

K803013 · Laboratory Products, Inc. · Chemistry
Jan 1981
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K803013 is an FDA 510(k) clearance for the CHLORIDE/TCO2 ANALYZER REAGENTS, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 2, 1981, 35 days after receiving the submission on November 28, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.

Submission Details

510(k) Number K803013 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1980
Decision Date January 02, 1981
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHJ — Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1170