Cleared Traditional

K924021 - POWER SUPPLY

K924021 is an FDA 510(k) clearance for POWER SUPPLY, manufactured by The Binding Site, Ltd.. The device is a Class 1 Hematology device with product code JJN cleared through the Traditional 510(k) pathway after a 170-day FDA review.

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

FDA 510(k) Submission Details - K924021

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 113d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

JJN Device Classification - Class 1, General Controls

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 23
Devices cleared under the same product code (JJN) and FDA review panel - the closest regulatory comparables to K924021.
ELECTROPHORESIS TANK
K924020 · The Binding Site, Ltd. · Dec 1992
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
STAVIP 3000
K864436 · Roseburg SA · Mar 1987
ELECTROPHORESIS WORK CENTER (EWC)
K861414 · Helena Laboratories · Aug 1986