Cleared Traditional

K893916 - EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410

K893916 is an FDA 510(k) clearance for EMDS CHOLESTEROL (CHO), manufactured by Em Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K893916 · Em Diagnostic Systems, Inc. · Chemistry device
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Aug 1989
Decision
90d
Days
Class 1
Risk

K893916 is an FDA 510(k) clearance for the EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 28, 1989 after a review of 90 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K893916

510(k) Number K893916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1989
Decision Date August 28, 1989
Days to Decision 90 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
2d slower than avg
Panel avg: 88d · This submission: 90d
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 K893916.
IMMUNOTECH CHOLESTEROL TEST
K897036 · Immunotech Corp. · Mar 1990
COBAS READY CHOLESTEROL REAGENT
K896239 · Roche Diagnostic Systems, Inc. · Feb 1990
VISION WHOLE BLOOD HDL CHOLESTEROL
K895158 · Abbott Laboratories · Oct 1989
CHOLESTEROL REAGENT SET
K893479 · American Monitor Corp. · Jun 1989
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922 · American Research Products Co. · Jun 1989
CLA 200 CHEMPRO(R) LIPID ANALYZER
K892238 · Johnson & Johnson Professionals, Inc. · Jun 1989