Cleared Traditional

K772176 - CYSTIC FIBROSIS TESTING INSTRUMENT

K772176 is an FDA 510(k) clearance for CYSTIC FIBROSIS TESTING INSTRUMENT, manufactured by Laboratory Equipment Design Co.. The device is a Class 1 Chemistry device with product code JJN cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K772176 · Laboratory Equipment Design Co. · Chemistry device
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Dec 1977
Decision
29d
Days
Class 1
Risk

K772176 is an FDA 510(k) clearance for the CYSTIC FIBROSIS TESTING INSTRUMENT. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by Laboratory Equipment Design Co. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977 after a review of 29 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 Laboratory Equipment Design Co. devices

FDA 510(k) Submission Details - K772176

510(k) Number K772176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1977
Decision Date December 20, 1977
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 K772176.
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 POWER SUPPLY TESTER
K771322 · Corning Medical & Scientific · Oct 1977
ELECTROPHORESIS OVEN THERMOMETER
K771323 · Corning Medical & Scientific · Aug 1977
AGARO-GEL, PRODUCT # A1266
K760131 · Sigma Chemical Co. · Jul 1976