Cleared Traditional

POWER SUPPLY (K924021) - FDA 510(k) Clearance

Class I Hematology device.

K924021 · The Binding Site, Ltd. · Hematology device
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Jan 1993
Decision
170d
Days
Class 1
Risk

K924021 is an FDA 510(k) clearance for the POWER SUPPLY. 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 January 28, 1993 after a review of 170 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2485 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Binding Site, Ltd. devices

Submission Details

510(k) Number K924021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date January 28, 1993
Days to Decision 170 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 113d · This submission: 170d
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 K924021.
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