Cleared Traditional

K771322 - ELECTROPHORESIS POWER SUPPLY TESTER

K771322 is an FDA 510(k) clearance for ELECTROPHORESIS POWER SUPPLY TESTER, 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 92-day FDA review.

K771322 · Corning Medical & Scientific · Chemistry device
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Oct 1977
Decision
92d
Days
Class 1
Risk

K771322 is an FDA 510(k) clearance for the ELECTROPHORESIS POWER SUPPLY TESTER. 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 October 18, 1977 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Corning Medical & Scientific devices

FDA 510(k) Submission Details - K771322

510(k) Number K771322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1977
Decision Date October 18, 1977
Days to Decision 92 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
4d slower than avg
Panel avg: 88d · This submission: 92d
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 K771322.
AGAROSE BARBITAL-EDTA BUFFER
K792553 · Electrophoresis Corp. of America · Jan 1980
BUFFERIZER
K791144 · Helena Laboratories · Aug 1979
AUTOMATED ELECTROPHORESES MACHINE
K791111 · Gelman Sciences, Inc. · Jul 1979
ELECTROPHORESIS OVEN THERMOMETER
K771323 · Corning Medical & Scientific · Aug 1977
AGARO-GEL, PRODUCT # A1266
K760131 · Sigma Chemical Co. · Jul 1976