Cleared Traditional

K945408 - 340-CHLORIDE FOR DISCRETE RANDOM ACCESS...

K945408 is the FDA 510(k) clearance for 340-CHLORIDE FOR DISCRETE RANDOM ACCESS... by Catachem, Inc.. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K945408 · Catachem, Inc. · Chemistry device
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Feb 1995
Decision
111d
Days
Class 2
Risk

K945408 is an FDA 510(k) clearance for the 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Catachem, Inc. (Bridgeport, US). The FDA issued a Cleared decision on February 22, 1995 after a review of 111 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 Catachem, Inc. devices

Submission Details

510(k) Number K945408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1994
Decision Date February 22, 1995
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
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 K945408.
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