Cleared Traditional

K897162 - COULTER CHOLESTEROL REAGENT

K897162 is the FDA 510(k) clearance for COULTER CHOLESTEROL REAGENT by Coulter Electronics, Inc.. It is a Class 1 Chemistry device (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

Submission Details

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.

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 121
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K897162.
SYNERMED CHOLESTEROL REAGENT KIT
K903015 · Synermed, Inc. · Oct 1990
LIQUID STABLE CHOLESTEROL REAGENT KIT
K902678 · Trace Scientific , Ltd. · Sep 1990
CHOLESTEROL (RATE) REAGENT
K902098 · Sigma Chemical Co. · Aug 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