FDA product code JLH: Titrimetric, Fatty Acids

JLH is the FDA product code for titrimetric, fatty acids. It is a Class I device, regulated under 21 CFR 862.1290 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JLH. The average 510(k) review took 37 days (median 37). FDA has posted 1 recall for JLH devices.

Classification

Compare with all 510(k) review times · Search every JLH clearance

Top JLH applicants

Most recent JLH clearances

Recalls for JLH devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-05-10.

Frequently asked questions

What is FDA product code JLH?

JLH is the FDA product code for titrimetric, fatty acids. It is a Class I device, regulated under 21 CFR 862.1290 and reviewed by the Clinical Chemistry panel.

What device class is JLH?

Class I, regulation 21 CFR 862.1290. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code JLH?

Across 1 cleared submissions the average was 37 days from receipt to decision (median 37).

Which companies have the most JLH clearances?

Volu Sol Medical Industries (1).

Have JLH devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2021-05-10.

Next steps

• Run an FDA pathway report with predicate devices for product code JLH
• Run a recall and safety report across every JLH manufacturer
• Watch product code JLH for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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