Cleared Traditional

K842320 - TDX REA CHOLESTEROL

K842320 is an FDA 510(k) clearance for TDX REA CHOLESTEROL, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K842320 · Abbott Laboratories · Chemistry device
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Aug 1984
Decision
64d
Days
Class 1
Risk

K842320 is an FDA 510(k) clearance for the TDX REA CHOLESTEROL. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 15, 1984 after a review of 64 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K842320

510(k) Number K842320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date August 15, 1984
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 140
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K842320.
PDA CHOLESTEROL
K843510 · Abbott Laboratories · Sep 1984
SYSTEMATE CHOLESTEROL 67222
K843327 · Em Diagnostic Systems, Inc. · Sep 1984
CHOLESTEROL ASSSAY KIT
K842160 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
MULTIPLE CHEM. MODULE FOR ANALYSIS
K841182 · Beckman Instruments, Inc. · May 1984
CHOLESTEROL REAGENT SET ENZYMATIC
K841053 · Medical Specialties, Inc. · May 1984
PARAMAX CHOLESTEROL REAGENT
K840776 · American Dade · Apr 1984