Cleared Traditional

K802371 - URIC ACID/ALDH

K802371 is an FDA 510(k) clearance for URIC ACID/ALDH, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code CDO cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K802371 · Boehringer Mannheim Corp. · Chemistry device
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Oct 1980
Decision
24d
Days
Class 1
Risk

K802371 is an FDA 510(k) clearance for the URIC ACID/ALDH. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Walker, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 24 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K802371

510(k) Number K802371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1980
Decision Date October 23, 1980
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 23
Devices cleared under the same product code (CDO) and FDA review panel - the closest regulatory comparables to K802371.
ULTRACHEM URIC ACID AIDH, #65047
K821465 · Emd Chemicals, Inc. · Jun 1982
URICASE (U.V.) URIC ACID
K821167 · Syn-Kit, Inc. · May 1982
ULTRACHEM URIC ACID ALDH, ITEM #65047
K812500 · Harleco · Sep 1981
CENTRIFICHEM URIC ACID
K800130 · Union Carbide Corp. · Feb 1980
ACID REAGENT, URIC SINGLE VIAL
K781996 · Calbiochem-Behring Corp. · Jan 1979
PRINCETON BIOMEDIX URICASE (UV)
K780859 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1978