Cleared Traditional

K902918 - SYNERMED SERUM IRON REAGENT KIT

K902918 is the FDA 510(k) clearance for SYNERMED SERUM IRON REAGENT KIT by Synermed, Inc.. It is a Class 1 Chemistry device (product code CFM) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K902918 · Synermed, Inc. · Chemistry device
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Jul 1990
Decision
28d
Days
Class 1
Risk

K902918 is an FDA 510(k) clearance for the SYNERMED SERUM IRON REAGENT KIT. Classified as Bathophenanthroline, Colorimetry, Iron (non-heme) (product code CFM), Class I - General Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on July 31, 1990 after a review of 28 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 Synermed, Inc. devices

Submission Details

510(k) Number K902918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date July 31, 1990
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 17
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