FDA product code CDG: Chromatography Separation/Zimmerman 17-Ketogenic Steroids

CDG is the FDA product code for chromatography separation/zimmerman 17-ketogenic steroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CDG. The average 510(k) review took 21 days (median 21).

Classification

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

Top CDG applicants

Most recent CDG clearances

Recalls for CDG devices

openFDA lists no recalls for product code CDG.

Frequently asked questions

What is FDA product code CDG?

CDG is the FDA product code for chromatography separation/zimmerman 17-ketogenic steroids. It is a Class I device, regulated under 21 CFR 862.1385 and reviewed by the Clinical Chemistry panel.

What device class is CDG?

Class I, regulation 21 CFR 862.1385. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).

Which companies have the most CDG clearances?

Eppendorf-Brinkmann, Inc. (1).

Next steps

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