Cleared Traditional

K932528 - OLYMPUS CHLORID REAGENT, MODIFIED

K932528 is an FDA 510(k) clearance for OLYMPUS CHLORID REAGENT, manufactured by Olympus Corp.. The device is a Class 2 Chemistry device with product code CHJ cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K932528 · Olympus Corp. · Chemistry device
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Sep 1993
Decision
148d
Days
Class 2
Risk

K932528 is an FDA 510(k) clearance for the OLYMPUS CHLORID REAGENT, MODIFIED. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on September 17, 1993 after a review of 148 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 Olympus Corp. devices

FDA 510(k) Submission Details - K932528

510(k) Number K932528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1993
Decision Date September 17, 1993
Days to Decision 148 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
60d slower than avg
Panel avg: 88d · This submission: 148d
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 K932528.
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