Cleared Traditional

K892929 - TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES

K892929 is an FDA 510(k) clearance for TECHNICON AXON TM SYSTEM ADDITIONAL ANA..., manufactured by Technicon Instruments Corp.. The device is a Class 2 Chemistry device with product code CHJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K892929 · Technicon Instruments Corp. · Chemistry device
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Jul 1989
Decision
90d
Days
Class 2
Risk

K892929 is an FDA 510(k) clearance for the TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 20, 1989 after a review of 90 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K892929

510(k) Number K892929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date July 20, 1989
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
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 K892929.
CHLORIDE REAGENT
K911297 · Intersect Systems, Inc. · Apr 1991
CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED
K910133 · Olympus Corp. · Feb 1991
CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA.
K901500 · Olympus Corp. · Jul 1990
BIOTROL CHLORIDE
K890015 · Biotrol, USA, Inc. · Feb 1989
TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE
K884601 · Technicon Instruments Corp. · Jan 1989
CHLORIDE TEST (CL) ITEM #65659
K884706 · Em Diagnostic Systems, Inc. · Jan 1989