Cleared Traditional

UV URIC ACID STANDARDS (K801501) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K801501 · The Dow Chemical Co. · Chemistry device
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Sep 1980
Decision
91d
Days
Class 2
Risk

K801501 is an FDA 510(k) clearance for the UV URIC ACID STANDARDS. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all The Dow Chemical Co. devices

Submission Details

510(k) Number K801501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1980
Decision Date September 26, 1980
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 46
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K801501.
SYVA ADVANCE STANDARDIZATION KIT 01
K820698 · Syva Co. · Apr 1982
BIO SET TM SUBSTRATE CALIBRATORS
K810963 · Boehringer Mannheim Corp. · Apr 1981
EMIT-TFG PRISMA THYROXINE CALIBRATORS
K810587 · Syva Co. · Mar 1981
EMIT AAII THYROXINE CALIBRATORS
K801287 · Syva Co. · Jun 1980
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.
K800206 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1980
SPECTRO-SUR SET
K791315 · Helena Laboratories · Aug 1979