Cleared Traditional

ELECTROPHORESIS TANK (K924020) - FDA 510(k) Clearance

Class I Chemistry device.

K924020 · The Binding Site, Ltd. · Chemistry device
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Dec 1992
Decision
139d
Days
Class 1
Risk

K924020 is an FDA 510(k) clearance for the ELECTROPHORESIS TANK. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2485 - 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 Binding Site, Ltd. devices

Submission Details

510(k) Number K924020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date December 28, 1992
Days to Decision 139 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 88d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJN Apparatus, Electrophoresis, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2485
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 - JJN Apparatus, Electrophoresis, For Clinical Use

All 33
Devices cleared under the same product code (JJN) and FDA review panel - the closest regulatory comparables to K924020.
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
K881852 · Helena Laboratories · Jul 1988
HELENA REP GEL PROCESSOR
K882163 · Helena Laboratories · Jun 1988
RAPID ELECTROPHORESIS SYSTEM (REP)
K873352 · Helena Laboratories · Sep 1987
ELECTROPHORESIS WORK CENTER (EWC)
K861414 · Helena Laboratories · Aug 1986
TITAN GEL HIGH RESOLUTION SERUM PROTEIN
K821688 · Helena Laboratories · Jun 1982
TITANAN GEL SERUM PROTEIN ELECTROPHORES
K821517 · Helena Laboratories · Jun 1982