Cleared Traditional

K981581 - IRON

K981581 is an FDA 510(k) clearance for IRON, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CFM cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K981581 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
35d
Days
Class 1
Risk

K981581 is an FDA 510(k) clearance for the IRON. Classified as Bathophenanthroline, Colorimetry, Iron (non-heme) (product code CFM), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on June 8, 1998 after a review of 35 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K981581

510(k) Number K981581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date June 08, 1998
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

CFM Device Classification - Class 1, General Controls

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 17
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