Cleared Traditional

K922921 - KING DIAGNOSTICS CHLORIDE REAGENT

K922921 is an FDA 510(k) clearance for KING DIAGNOSTICS CHLORIDE REAGENT, manufactured by King Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CHJ cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K922921 · King Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
110d
Days
Class 2
Risk

K922921 is an FDA 510(k) clearance for the KING DIAGNOSTICS CHLORIDE REAGENT. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 5, 1992 after a review of 110 days - within the typical 510(k) review window.

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 King Diagnostics, Inc. devices

FDA 510(k) Submission Details - K922921

510(k) Number K922921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1992
Decision Date October 05, 1992
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
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 K922921.
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OLYMPUS CHLORIDE REAGENT
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OLYMPUS CHLORIDE REAGENT
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URINE CHLORIDE
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CHLORIDE REAGENT
K911297 · Intersect Systems, Inc. · Apr 1991