Cleared Traditional

K821303 - HI-PHORE HIGH RESOLUTION ELECTROPHORES

K821303 is an FDA 510(k) clearance for HI-PHORE HIGH RESOLUTION ELECTROPHORES, manufactured by Gelman Sciences, Inc.. The device is a Class 1 Chemistry device with product code JJN cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K821303 · Gelman Sciences, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
May 1982
Decision
8d
Days
Class 1
Risk

K821303 is an FDA 510(k) clearance for the HI-PHORE HIGH RESOLUTION ELECTROPHORES. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 12, 1982 after a review of 8 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 Gelman Sciences, Inc. devices

FDA 510(k) Submission Details - K821303

510(k) Number K821303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date May 12, 1982
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 88d · This submission: 8d
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 K821303.
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AUTOMATED ELECTROPHORESIS SYSTEM
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GENERAL PROCEDURE AGAROSE FILM
K802396 · Electrophoresis Corp. of America · Nov 1980
CORNING 60 VOLT POWER SUPPLY
K801893 · Corning Medical & Scientific · Sep 1980