Cleared Traditional

K955752 - OLYMPUS URIC ACID REAGENT

K955752 is an FDA 510(k) clearance for OLYMPUS URIC ACID REAGENT, manufactured by Olympus America, Inc.. The device is a Class 1 Chemistry device with product code CDO cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K955752 · Olympus America, Inc. · Chemistry device
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Jan 1996
Decision
43d
Days
Class 1
Risk

K955752 is an FDA 510(k) clearance for the OLYMPUS URIC ACID REAGENT. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on January 31, 1996 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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 Olympus America, Inc. devices

FDA 510(k) Submission Details - K955752

510(k) Number K955752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1995
Decision Date January 31, 1996
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

CDO Device Classification - Class 1, General Controls

Product Code CDO Acid, Uric, Uricase (u.v.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CDO Acid, Uric, Uricase (u.v.)

All 26
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K955752.
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K923765 · Em Diagnostic Systems, Inc. · Sep 1992
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K903335 · Em Diagnostic Systems, Inc. · Aug 1990