Cleared Traditional

K911297 - CHLORIDE REAGENT

K911297 is the FDA 510(k) clearance for CHLORIDE REAGENT by Intersect Systems, Inc.. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K911297 · Intersect Systems, Inc. · Chemistry device
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Apr 1991
Decision
22d
Days
Class 2
Risk

K911297 is an FDA 510(k) clearance for the CHLORIDE REAGENT. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on April 16, 1991 after a review of 22 days - a notably fast clearance 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: 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 Intersect Systems, Inc. devices

Submission Details

510(k) Number K911297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1991
Decision Date April 16, 1991
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 41
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