Cleared Traditional

K822418 - ULTRACHEM ENZYMATIC CHOL. OXIDASE

K822418 is the FDA 510(k) clearance for ULTRACHEM ENZYMATIC CHOL. OXIDASE by Emd Chemicals, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K822418 · Emd Chemicals, Inc. · Chemistry device
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Sep 1982
Decision
34d
Days
Class 1
Risk

K822418 is an FDA 510(k) clearance for the ULTRACHEM ENZYMATIC CHOL. 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 September 14, 1982 after a review of 34 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 K822418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1982
Decision Date September 14, 1982
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 122
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K822418.
ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE
K823354 · Emd Chemicals, Inc. · Dec 1982
CHOLESTEROL CHOD-PAP TEST
K823302 · Boehringer Mannheim Corp. · Dec 1982
NEW ENZYMATIC SINGLE REAGENT FREE CHOL.
K822417 · Sclavo, Inc. · Oct 1982
ENZYMATIC CHOLESTERAL OXIDASE #650550
K821441 · Emd Chemicals, Inc. · Jun 1982
ENZYMATIC CHOLESTEROL REAGENT SYSTEM
K820473 · American Monitor Corp. · Mar 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K820263 · Eastman Kodak Company · Feb 1982