Cleared Traditional

GEMENI URIC ACID U.V. (K873358) - FDA 510(k) Clearance

Class I Chemistry device.

K873358 · Electro-Nucleonics Laboratories, Inc. · Chemistry device
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Sep 1987
Decision
21d
Days
Class 1
Risk

K873358 is an FDA 510(k) clearance for the GEMENI URIC ACID U.V.. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on September 11, 1987 after a review of 21 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 Electro-Nucleonics Laboratories, Inc. devices

Submission Details

510(k) Number K873358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1987
Decision Date September 11, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 30
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K873358.
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K863660 · Em Diagnostic Systems, Inc. · Oct 1986