Cleared Traditional

K897162 - COULTER CHOLESTEROL REAGENT

K897162 is an FDA 510(k) clearance for COULTER CHOLESTEROL REAGENT, manufactured by Coulter Electronics, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K897162 · Coulter Electronics, Inc. · Chemistry device
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Mar 1990
Decision
91d
Days
Class 1
Risk

K897162 is an FDA 510(k) clearance for the COULTER CHOLESTEROL REAGENT. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on March 29, 1990 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K897162

510(k) Number K897162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1989
Decision Date March 29, 1990
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
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 186
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K897162.
LIQUID STABLE CHOLESTEROL REAGENT KIT
K902678 · Trace Scientific , Ltd. · Sep 1990
CHOLESTEROL (RATE) REAGENT
K902098 · Sigma Chemical Co. · Aug 1990
L.D.X LIPID MONITORING SYSTEM
K901900 · Cholestech Corp. · Jul 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
K900850 · Em Diagnostic Systems, Inc. · Mar 1990
IMMUNOTECH CHOLESTEROL TEST
K897036 · Immunotech Corp. · Mar 1990
COBAS READY CHOLESTEROL REAGENT
K896239 · Roche Diagnostic Systems, Inc. · Feb 1990