Cleared Traditional

K801893 - CORNING 60 VOLT POWER SUPPLY

K801893 is an FDA 510(k) clearance for CORNING 60 VOLT POWER SUPPLY, manufactured by Corning Medical & Scientific. The device is a Class 1 Chemistry device with product code JJN cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K801893 · Corning Medical & Scientific · Chemistry device
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Sep 1980
Decision
39d
Days
Class 1
Risk

K801893 is an FDA 510(k) clearance for the CORNING 60 VOLT POWER SUPPLY. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 39 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 Corning Medical & Scientific devices

FDA 510(k) Submission Details - K801893

510(k) Number K801893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1980
Decision Date September 16, 1980
Days to Decision 39 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
49d faster than avg
Panel avg: 88d · This submission: 39d
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 K801893.
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
HIPP BUFFER(NON-BARBITAL), P/N
K801378 · Gelman Sciences, Inc. · Jul 1980
AGAROSE BARBITAL BUFFER
K792547 · Electrophoresis Corp. of America · Jan 1980
AGAROSE BARBITAL-EDTA BUFFER
K792553 · Electrophoresis Corp. of America · Jan 1980