Cleared Traditional

K935136 - CHOLESTEROL (CHOL) TEST ITEM NO. 65410

K935136 is the FDA 510(k) clearance for CHOLESTEROL (CHOL) TEST ITEM NO. 65410 by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K935136 · Em Diagnostic Systems, Inc. · Chemistry device
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Dec 1993
Decision
49d
Days
Class 1
Risk

K935136 is an FDA 510(k) clearance for the CHOLESTEROL (CHOL) TEST ITEM NO. 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 December 16, 1993 after a review of 49 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K935136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date December 16, 1993
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 K935136.
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · Boehringer Mannheim Corp. · Jul 1995
ROCHE REAGENT
K941573 · Roche Diagnostic Systems, Inc. · Oct 1994
CHOLESTEROL ENZYMATIC ENDPOINT
K923504 · Randox Laboratories, Ltd. · Jan 1994
OLYMPUS CHOLESTEROL REAGENT
K925603 · Olympus Corp. · Feb 1993
CHOLESTEROL TEST ITEM# 42374/93, 42322/R1
K924508 · Em Diagnostic Systems, Inc. · Jan 1993
OLYMPUS CHOLESTEROL REAGENT
K922231 · Olympus Corp. · Nov 1992