JLGClass I

Conversion To Ferric Hydroxymates (colorimetric), Fatty Acids

Clinical Chemistry · 21 CFR 862.1290

MDR events0All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances2All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Randox Laboratories, Limited
TerminatedUnknown
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
Z-0367-2020 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB

510(k) clearances

2 clearances for this product code