Cleared Traditional

K812500 - ULTRACHEM URIC ACID ALDH

K812500 is the FDA 510(k) clearance for ULTRACHEM URIC ACID ALDH by Harleco. It is a Class 1 Chemistry device (product code CDO) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K812500 · Harleco · Chemistry device
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Sep 1981
Decision
23d
Days
Class 1
Risk

K812500 is an FDA 510(k) clearance for the ULTRACHEM URIC ACID ALDH, ITEM #65047. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 23 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 Harleco devices

Submission Details

510(k) Number K812500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 23, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
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 23
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K812500.
ULTRACHEM URIC ACID AIDH #65047
K821474 · Emd Chemicals, Inc. · Jun 1982
ULTRACHEM URIC ACID AIDH, #65047
K821465 · Emd Chemicals, Inc. · Jun 1982
URICASE (U.V.) URIC ACID
K821167 · Syn-Kit, Inc. · May 1982
URIC ACID/ALDH
K802371 · Boehringer Mannheim Corp. · Oct 1980
CENTRIFICHEM URIC ACID
K800130 · Union Carbide Corp. · Feb 1980
ACID REAGENT, URIC SINGLE VIAL
K781996 · Calbiochem-Behring Corp. · Jan 1979