Cleared Traditional

K897036 - IMMUNOTECH CHOLESTEROL TEST

K897036 is the FDA 510(k) clearance for IMMUNOTECH CHOLESTEROL TEST by Immunotech Corp.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K897036 · Immunotech Corp. · Chemistry device

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Mar 1990

Decision

78d

Days

Class 1

Risk

K897036 is an FDA 510(k) clearance for the IMMUNOTECH CHOLESTEROL TEST. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on March 6, 1990 after a review of 78 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 Immunotech Corp. devices

Submission Details

510(k) Number	K897036 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 18, 1989
Decision Date	March 06, 1990
Days to Decision	78 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

10d faster than avg

Panel avg: 88d · This submission: 78d

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 126

Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K897036.

CHOLESTEROL (RATE) REAGENT

K902098 · Sigma Chemical Co. · Aug 1990

COULTER CHOLESTEROL REAGENT

K897162 · Coulter Electronics, Inc. · Mar 1990

EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410

K900850 · Em Diagnostic Systems, Inc. · Mar 1990

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K897036

Immunotech Corp.

Boston, MA · US

FRANCIS E CAPITANIO

Regulatory profile

37 submissions 37 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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