Cleared Traditional

K935228 - MODEL 644 SWEAT DILUENT

K935228 is an FDA 510(k) clearance for MODEL 644 SWEAT DILUENT, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code CGZ cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K935228 · Ciba Corning Diagnostics Corp. · Chemistry device
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Aug 1994
Decision
273d
Days
Class 2
Risk

K935228 is an FDA 510(k) clearance for the MODEL 644 SWEAT DILUENT. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on August 1, 1994 after a review of 273 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K935228

510(k) Number K935228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date August 01, 1994
Days to Decision 273 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
185d slower than avg
Panel avg: 88d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGZ Device Classification - Class 2, Special Controls

Product Code CGZ Electrode, Ion-specific, 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 - CGZ Electrode, Ion-specific, Chloride

All 24
Devices cleared under the same product code (CGZ) and FDA review panel - the closest regulatory comparables to K935228.
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