Cleared Traditional

K811100 - GELMAN ELECTROPHORESIS CONTROL

K811100 is the FDA 510(k) clearance for GELMAN ELECTROPHORESIS CONTROL by Gelman Sciences, Inc.. It is a Class 1 Chemistry device (product code JJY) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K811100 · Gelman Sciences, Inc. · Chemistry device
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May 1981
Decision
9d
Days
Class 1
Risk

K811100 is an FDA 510(k) clearance for the GELMAN ELECTROPHORESIS CONTROL. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1981 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Gelman Sciences, Inc. devices

Submission Details

510(k) Number K811100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1981
Decision Date May 01, 1981
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 88d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 474
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K811100.
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM
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DOXEPIN/DESMETHLDOXEPIN/LITHIUM
K811467 · Ortho Diagnostic Systems, Inc. · Jun 1981
MULTIANALYTE CONTROLS, ALL KINDS
K811182 · Fisher Scientific Co., LLC · May 1981
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K803098 · American Diagnostic Corp. · Jan 1981
KEMTROL SERUM CONTROL-NORMAL
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