Cleared Traditional

K823187 - CHOLESTEROL HIGH SENSIT. REAGENT ENZYM

K823187 is an FDA 510(k) clearance for CHOLESTEROL HIGH SENSIT. REAGENT ENZYM, manufactured by Rai, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K823187 · Rai, Inc. · Chemistry device
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Nov 1982
Decision
27d
Days
Class 1
Risk

K823187 is an FDA 510(k) clearance for the CHOLESTEROL HIGH SENSIT. REAGENT ENZYM. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Rai, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 27 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 Rai, Inc. devices

FDA 510(k) Submission Details - K823187

510(k) Number K823187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date November 22, 1982
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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 192
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K823187.
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE
K830309 · Emd Chemicals, Inc. · Feb 1983
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
ULTRACHEM ENZYMATIC CHOL. OXIDASE
K822418 · Emd Chemicals, Inc. · Sep 1982
ENZYMATIC CHOLESTERAL OXIDASE #650550
K821441 · Emd Chemicals, Inc. · Jun 1982