FDA product code JGE: Turbidimetric Method, Globulin

JGE is the FDA product code for turbidimetric method, globulin. It is a Class I device, regulated under 21 CFR 862.1330 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JGE. The average 510(k) review took 22 days (median 22). FDA has posted 1 recall for JGE devices.

Classification

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

Top JGE applicants

Most recent JGE clearances

Recalls for JGE devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-04-22.

Frequently asked questions

What is FDA product code JGE?

JGE is the FDA product code for turbidimetric method, globulin. It is a Class I device, regulated under 21 CFR 862.1330 and reviewed by the Clinical Chemistry panel.

What device class is JGE?

Class I, regulation 21 CFR 862.1330. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 22 days from receipt to decision (median 22).

Which companies have the most JGE clearances?

Exigent Diagnostics, Inc. (1).

Have JGE devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2011-04-22.

Next steps

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