FDA product code CCY: Zimmerman (Spectrophotometric), 17-Ketosteroids

CCY is the FDA product code for zimmerman (spectrophotometric), 17-ketosteroids. It is a Class I device, regulated under 21 CFR 862.1430 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CCY. The average 510(k) review took 30 days (median 30).

Classification

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

Top CCY applicants

Most recent CCY clearances

Recalls for CCY devices

openFDA lists no recalls for product code CCY.

Frequently asked questions

What is FDA product code CCY?

CCY is the FDA product code for zimmerman (spectrophotometric), 17-ketosteroids. It is a Class I device, regulated under 21 CFR 862.1430 and reviewed by the Clinical Chemistry panel.

What device class is CCY?

Class I, regulation 21 CFR 862.1430. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).

Which companies have the most CCY clearances?

Hycel, Inc. (1).

Next steps

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