FDA product code JJL: Plasma Viscometer For Clinical Use

JJL is the FDA product code for plasma viscometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2920 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JJL. The average 510(k) review took 33 days (median 33).

Classification

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

Top JJL applicants

Most recent JJL clearances

Recalls for JJL devices

openFDA lists no recalls for product code JJL.

Frequently asked questions

What is FDA product code JJL?

JJL is the FDA product code for plasma viscometer for clinical use. It is a Class I device, regulated under 21 CFR 862.2920 and reviewed by the Clinical Chemistry panel.

What device class is JJL?

Class I, regulation 21 CFR 862.2920. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 33 days from receipt to decision (median 33).

Which companies have the most JJL clearances?

Coulter Electronics, Inc. (1).

Next steps

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