Cleared Traditional

COMBO-FER IRON DIAGNOSTIC (K811954) - FDA 510(k) Clearance

Class I Chemistry device.

K811954 · Immuno Assay Corp. · Chemistry device
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Jul 1981
Decision
19d
Days
Class 1
Risk

K811954 is an FDA 510(k) clearance for the COMBO-FER IRON DIAGNOSTIC. Classified as Radiometric, Fe59, Iron Binding Capacity (product code JQG), Class I - General Controls.

Submitted by Immuno Assay Corp. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1981 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - 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 Immuno Assay Corp. devices

Submission Details

510(k) Number K811954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1981
Decision Date July 27, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQG Radiometric, Fe59, Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
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.