Cleared Traditional

K823354 - ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE

K823354 is the FDA 510(k) clearance for ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE by Emd Chemicals, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K823354 · Emd Chemicals, Inc. · Chemistry device
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Dec 1982
Decision
47d
Days
Class 1
Risk

K823354 is an FDA 510(k) clearance for the ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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

Submission Details

510(k) Number K823354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1982
Decision Date December 22, 1982
Days to Decision 47 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
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 121
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K823354.
WAKO FREE CHOLESTEROL C TEST
K830761 · Wako Chemicals USA, Inc. · Apr 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA
K830239 · Emd Chemicals, Inc. · Apr 1983
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE
K830309 · Emd Chemicals, Inc. · Feb 1983
CHOLESTEROL CHOD-PAP TEST
K823302 · Boehringer Mannheim Corp. · Dec 1982
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
K822417 · Sclavo, Inc. · Oct 1982
ULTRACHEM ENZYMATIC CHOL. OXIDASE
K822418 · Emd Chemicals, Inc. · Sep 1982