Cleared Traditional

K834396 - DIRECT IRON REAGENT SET

K834396 is the FDA 510(k) clearance for DIRECT IRON REAGENT SET by Seragen Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CFM) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K834396 · Seragen Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1984
Decision
69d
Days
Class 1
Risk

K834396 is an FDA 510(k) clearance for the DIRECT IRON REAGENT SET. Classified as Bathophenanthroline, Colorimetry, Iron (non-heme) (product code CFM), Class I - General Controls.

Submitted by Seragen Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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 Seragen Diagnostics, Inc. devices

Submission Details

510(k) Number K834396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date February 21, 1984
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFM Bathophenanthroline, Colorimetry, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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 - CFM Bathophenanthroline, Colorimetry, Iron (non-heme)

All 18
Devices cleared under the same product code (CFM) and FDA review panel - the closest regulatory comparables to K834396.
SERUM IRON & SERUM IRON BINDING CAPACI
K842155 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
SERUM IRON & SERUM IRON BINDING CAPACITY
K842156 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
TDX REA IRON DIAGNOSTIC KIT
K842505 · Abbott Laboratories · Aug 1984
FEB TEST
K830564 · Wako Chemicals USA, Inc. · Mar 1983
CORNING 902 SODIUM POTASSIUM ANALYZER
K820629 · Corning Medical & Scientific · Mar 1982
ELVI SERUM IRON
K792406 · Volu Sol Medical Industries · Dec 1979