Cleared Traditional

K821474 - ULTRACHEM URIC ACID AIDH #65047

K821474 is an FDA 510(k) clearance for ULTRACHEM URIC ACID AIDH #65047, manufactured by Emd Chemicals, Inc.. The device is a Class 1 Chemistry device with product code CDO cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K821474 · Emd Chemicals, Inc. · Chemistry device
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Jun 1982
Decision
16d
Days
Class 1
Risk

K821474 is an FDA 510(k) clearance for the ULTRACHEM URIC ACID AIDH #65047. Classified as Acid, Uric, Uricase (u.v.) (product code CDO), Class I - General Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982 after a review of 16 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 Emd Chemicals, Inc. devices

FDA 510(k) Submission Details - K821474

510(k) Number K821474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date June 03, 1982
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 K821474.
ROCHE REAGENTS REAGENT FOR URIC ACID
K844986 · Roche Diagnostic Systems, Inc. · Jan 1985
URIC ACID 75CDO
K822884 · Technicon Instruments Corp. · Oct 1982
ULTRACHEM URIC ACID AIDH
K821872 · Harleco Diagnostics · Jul 1982
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