Cleared Traditional

K770998 - CHOLESTEROL REAGENT SET

K770998 is an FDA 510(k) clearance for CHOLESTEROL REAGENT SET, manufactured by The Dow Chemical Co.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway .

K770998 · The Dow Chemical Co. · Chemistry device
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Jun 1977
Decision
-
Days
Class 1
Risk

K770998 is an FDA 510(k) clearance for the CHOLESTEROL REAGENT SET. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1977.

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 The Dow Chemical Co. devices

FDA 510(k) Submission Details - K770998

510(k) Number K770998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1977
Decision Date June 02, 1977
Days to Decision -
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
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 188
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K770998.
HOLESTEROL DELTA TEST ASSAY
K771582 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977
ENZYMATIC CHOLESTEROL REAGENT SET
K770909 · American Monitor Corp. · Jul 1977
CHOLESTEROL REAGENT
K770483 · Smithkline Diagnostics, Inc. · Jun 1977
REAGENT SET, CHOLESTEROL, CAT NO. 4024
K770747 · American Monitor Corp. · Jun 1977
CHOLESTEROL TEST
K770265 · Sclavo, Inc. · Feb 1977
GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT
K761136 · Beckman Instruments, Inc. · Jan 1977