Cleared Traditional

K802395 - SPECIAL PROCEDURE AQAROSE FILM

K802395 is an FDA 510(k) clearance for SPECIAL PROCEDURE AQAROSE FILM, manufactured by Electrophoresis Corp.. The device is a Class 1 Chemistry device with product code JJN cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K802395 · Electrophoresis Corp. · Chemistry device
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Nov 1980
Decision
55d
Days
Class 1
Risk

K802395 is an FDA 510(k) clearance for the SPECIAL PROCEDURE AQAROSE FILM. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by Electrophoresis Corp. (Mchenry, US). The FDA issued a Cleared decision on November 26, 1980 after a review of 55 days - a notably fast clearance cycle.

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: 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 Electrophoresis Corp. devices

FDA 510(k) Submission Details - K802395

510(k) Number K802395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1980
Decision Date November 26, 1980
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
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 24
Devices cleared under the same product code (JJN) and FDA review panel - the closest regulatory comparables to K802395.
TITANAN GEL SERUM PROTEIN ELECTROPHORES
K821517 · Helena Laboratories · Jun 1982
HI-PHORE HIGH RESOLUTION ELECTROPHORES
K821303 · Gelman Sciences, Inc. · May 1982
AUTOMATED ELECTROPHORESIS SYSTEM
K803281 · Helena Laboratories · Jan 1981
GENERAL PROCEDURE AGAROSE FILM
K802396 · Electrophoresis Corp. of America · Nov 1980
CORNING 60 VOLT POWER SUPPLY
K801893 · Corning Medical & Scientific · Sep 1980
HIPP BUFFER(NON-BARBITAL), P/N
K801378 · Gelman Sciences, Inc. · Jul 1980