Cleared Traditional

K843327 - SYSTEMATE CHOLESTEROL 67222

K843327 is the FDA 510(k) clearance for SYSTEMATE CHOLESTEROL 67222 by Em Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K843327 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1984
Decision
18d
Days
Class 1
Risk

K843327 is an FDA 510(k) clearance for the SYSTEMATE CHOLESTEROL 67222. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1984 after a review of 18 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 K843327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1984
Decision Date September 14, 1984
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 125
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K843327.
CHOLESTEROL METHOD
K852863 · Catachem, Inc. · Jul 1985
PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE
K844655 · Boehringer Mannheim Corp. · Jan 1985
PDA CHOLESTEROL
K843510 · Abbott Laboratories · Sep 1984
CHOLESTEROL ASSSAY KIT
K842160 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
TDX REA CHOLESTEROL
K842320 · Abbott Laboratories · Aug 1984
MULTIPLE CHEM. MODULE FOR ANALYSIS
K841182 · Beckman Instruments, Inc. · May 1984