FDA product code JHL: Microdensitometry Method, Lipoproteins

JHL is the FDA product code for microdensitometry method, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JHL. The average 510(k) review took 51 days (median 51).

Classification

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

Top JHL applicants

Most recent JHL clearances

Recalls for JHL devices

openFDA lists no recalls for product code JHL.

Frequently asked questions

What is FDA product code JHL?

JHL is the FDA product code for microdensitometry method, lipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.

What device class is JHL?

Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 51 days from receipt to decision (median 51).

Which companies have the most JHL clearances?

Beckman Instruments, Inc. (1).

Next steps

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

All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times