FDA product code JGX: Turbidimetric Method, Triglycerides

JGX is the FDA product code for turbidimetric method, triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JGX. The average 510(k) review took 60 days (median 60).

Classification

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

Top JGX applicants

Most recent JGX clearances

Recalls for JGX devices

openFDA lists no recalls for product code JGX.

Frequently asked questions

What is FDA product code JGX?

JGX is the FDA product code for turbidimetric method, triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel.

What device class is JGX?

Class I, regulation 21 CFR 862.1705. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 60 days from receipt to decision (median 60).

Which companies have the most JGX clearances?

Sterling Biochemical, Inc. (1).

Next steps

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