Cleared Traditional

ISOGEL AGAROSE (K841407) - FDA 510(k) Clearance

Class I Chemistry device.

K841407 · Fmc Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
468d
Days
Class 1
Risk

K841407 is an FDA 510(k) clearance for the ISOGEL AGAROSE. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by Fmc Corp. (Walker, US). The FDA issued a Cleared decision on July 16, 1985 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Fmc Corp. devices

Submission Details

510(k) Number K841407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1984
Decision Date July 16, 1985
Days to Decision 468 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
380d slower than avg
Panel avg: 88d · This submission: 468d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 9
Devices cleared under the same product code (JJN) and FDA review panel - the closest regulatory comparables to K841407.
HELENA REP GEL PROCESSOR
K882163 · Helena Laboratories · Jun 1988
RAPID ELECTROPHORESIS SYSTEM (REP)
K873352 · Helena Laboratories · Sep 1987
ELECTROPHORESIS WORK CENTER (EWC)
K861414 · Helena Laboratories · Aug 1986
TITAN GEL HIGH RESOLUTION SERUM PROTEIN
K821688 · Helena Laboratories · Jun 1982
TITANAN GEL SERUM PROTEIN ELECTROPHORES
K821517 · Helena Laboratories · Jun 1982
AUTOMATED ELECTROPHORESIS SYSTEM
K803281 · Helena Laboratories · Jan 1981