Cleared Traditional

K902173 - COULTER SERUM IRON/UIBC REAGENT

K902173 is the FDA 510(k) clearance for COULTER SERUM IRON/UIBC REAGENT by Coulter Corp.. It is a Class 1 Chemistry device (product code JIY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K902173 · Coulter Corp. · Chemistry device
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Jun 1990
Decision
29d
Days
Class 1
Risk

K902173 is an FDA 510(k) clearance for the COULTER SERUM IRON/UIBC REAGENT. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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 Coulter Corp. devices

Submission Details

510(k) Number K902173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1990
Decision Date June 12, 1990
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIY Photometric Method, 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 - JIY Photometric Method, Iron (non-heme)

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