Home › Device types › JLH
Titrimetric, Fatty Acids
FDA product code JLH · Class 1 · Clinical Chemistry
4
Registered devices
0
Adverse events
1
Recalls
1
510(k) clearances
Devices with this code
HR Series NEFA-HR(2) Color Reagent A — FUJIFILM WAKO PURE CHEMICAL CORPORATIONHR Series NEFA-HR(2) Solvent B — FUJIFILM WAKO PURE CHEMICAL CORPORATIONHR Series NEFA-HR(2) Solvent A — FUJIFILM WAKO PURE CHEMICAL CORPORATIONHR Series NEFA-HR(2) Color Reagent B — FUJIFILM WAKO PURE CHEMICAL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-10 | Randox Laboratories Ltd. | Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.