Cleared Traditional

PARAMAX CHLORIDE REAGENT (K841047) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841047 · American Dade · Toxicology device
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Apr 1984
Decision
38d
Days
Class 2
Risk

K841047 is an FDA 510(k) clearance for the PARAMAX CHLORIDE REAGENT. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984 after a review of 38 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Dade devices

Submission Details

510(k) Number K841047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date April 19, 1984
Days to Decision 38 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 87d · This submission: 38d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 52
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K841047.
CHLORIDE TEST (CL) ITEM #65659
K884706 · Em Diagnostic Systems, Inc. · Jan 1989
ROCHE REAGENT FOR CHLORIDE
K884013 · Roche Diagnostic Systems, Inc. · Dec 1988
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
K850334 · Roche Diagnostic Systems, Inc. · Mar 1985
PROCEDURE 460 FOR DETERM. OF CHLORIDE
K833166 · Sigma Chemical Co. · Oct 1983