Cleared Traditional

K770909 - ENZYMATIC CHOLESTEROL REAGENT SET

K770909 is an FDA 510(k) clearance for ENZYMATIC CHOLESTEROL REAGENT SET, manufactured by American Monitor Corp.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K770909 · American Monitor Corp. · Chemistry device
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Jul 1977
Decision
56d
Days
Class 1
Risk

K770909 is an FDA 510(k) clearance for the ENZYMATIC CHOLESTEROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977 after a review of 56 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 Monitor Corp. devices

FDA 510(k) Submission Details - K770909

510(k) Number K770909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1977
Decision Date July 14, 1977
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 K770909.
CHOLOPAP-HDL
K771586 · Advanced Biomedical Methods, Inc. · Sep 1977
MULTISTAT III CHOLESTEROL TEST
K771508 · Instrumentation Laboratory CO · Sep 1977
HOLESTEROL DELTA TEST ASSAY
K771582 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977
CHOLESTEROL REAGENT
K770483 · Smithkline Diagnostics, Inc. · Jun 1977
CHOLESTEROL REAGENT SET
K770998 · The Dow Chemical Co. · Jun 1977
REAGENT SET, CHOLESTEROL, CAT NO. 4024
K770747 · American Monitor Corp. · Jun 1977