Cleared Traditional

AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325 (K891922) - FDA 510(k) Clearance

Class I Chemistry device.

K891922 · American Research Products Co. · Chemistry device
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Jun 1989
Decision
81d
Days
Class 1
Risk

K891922 is an FDA 510(k) clearance for the AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 81 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 American Research Products Co. devices

Submission Details

510(k) Number K891922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1989
Decision Date June 16, 1989
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
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 53
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K891922.
COBAS READY CHOLESTEROL REAGENT
K896239 · Roche Diagnostic Systems, Inc. · Feb 1990
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · Abbott Laboratories · Oct 1989
EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410
K893916 · Em Diagnostic Systems, Inc. · Aug 1989
CLA 200 CHEMPRO(R) LIPID ANALYZER
K892238 · Johnson & Johnson Professionals, Inc. · Jun 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
K885023 · Em Diagnostic Systems, Inc. · Feb 1989
HDL CHOLESTEROL REAGENT
K872575 · Sigma Chemical Co. · Jul 1987