Cleared Traditional

K922921 - KING DIAGNOSTICS CHLORIDE REAGENT

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

K922921 · King Diagnostics, Inc. · Chemistry device
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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

Submission Details

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.

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 K922921.
OLYMPUS CHLORIDE REAGENT, MODIFICATION
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OLYMPUS CHLORID REAGENT, MODIFIED
K932528 · Olympus Corp. · Sep 1993
OLYMPUS CHLORIDE REAGENT
K925338 · Olympus Corp. · Dec 1992
OLYMPUS CHLORIDE REAGENT
K923610 · Olympus Corp. · Oct 1992
URINE CHLORIDE
K923036 · Heraeus Kulzer, Inc. · Sep 1992
CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED
K910133 · Olympus Corp. · Feb 1991