Cleared Traditional

K832438 - CHLORIDE REAGENT SET

K832438 is the FDA 510(k) clearance for CHLORIDE REAGENT SET by Amresco, Inc.. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K832438 · Amresco, Inc. · Chemistry device
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Jan 1984
Decision
179d
Days
Class 2
Risk

K832438 is an FDA 510(k) clearance for the CHLORIDE REAGENT SET. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 20, 1984 after a review of 179 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Amresco, Inc. devices

Submission Details

510(k) Number K832438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date January 20, 1984
Days to Decision 179 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 88d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 40
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K832438.
CHLORIDE TEST KIT
K842011 · Mallinckrodt Critical Care · Jun 1984
PARAMAX CHLORIDE REAGENT
K841047 · American Dade · Apr 1984
FLOW-PAC CHLORIDE REAGENT SET
K834333 · American Research Products Co. · Feb 1984
TECH. RA-1000 SYS SERUM CHLORIDE
K833746 · Technicon Instruments Corp. · Jan 1984
PROCEDURE 460 FOR DETERM. OF CHLORIDE
K833166 · Sigma Chemical Co. · Oct 1983
TPTZ CHLORIDE
K820235 · American Monitor Corp. · Feb 1982