Cleared Traditional

K941807 - INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT

K941807 is an FDA 510(k) clearance for INTERSECT SYSTEMS' NON-MERCURIC CHLORID..., manufactured by Intersect Systems, Inc.. The device is a Class 2 Chemistry device with product code CHG cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K941807 · Intersect Systems, Inc. · Chemistry device
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Sep 1994
Decision
155d
Days
Class 2
Risk

K941807 is an FDA 510(k) clearance for the INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT. Classified as Acid, Phosphoric-tungstic (spectrophotometric), Chloride (product code CHG), Class II - Special Controls.

Submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on September 14, 1994 after a review of 155 days - an extended review 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: 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 Intersect Systems, Inc. devices

FDA 510(k) Submission Details - K941807

510(k) Number K941807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1994
Decision Date September 14, 1994
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHG Device Classification - Class 2, Special Controls

Product Code CHG Acid, Phosphoric-tungstic (spectrophotometric), 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.