Cleared Traditional

K832438 - CHLORIDE REAGENT SET

K832438 is an FDA 510(k) clearance for CHLORIDE REAGENT SET, manufactured by Amresco, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K832438

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.

CHJ Device Classification - Class 2, Special Controls

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 48
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