FDA product code LJD: Assay, B Lymphocyte Marker

LJD is the FDA product code for assay, b lymphocyte marker. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under LJD. The average 510(k) review took 439 days (median 439).

Classification

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

Top LJD applicants

Most recent LJD clearances

Recalls for LJD devices

openFDA lists no recalls for product code LJD.

Frequently asked questions

What is FDA product code LJD?

LJD is the FDA product code for assay, b lymphocyte marker. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Immunology panel.

What device class is LJD?

Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 439 days from receipt to decision (median 439).

Which companies have the most LJD clearances?

Bd Becton Dickinson Vacutainer Systems Preanalytic (1).

Next steps

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