FDA product code CJN: Acid Phosphatase, Nitrophenylphosphate

CJN is the FDA product code for acid phosphatase, nitrophenylphosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under CJN. The average 510(k) review took 36 days (median 36).

Classification

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

Top CJN applicants

Most recent CJN clearances

Recalls for CJN devices

openFDA lists no recalls for product code CJN.

Frequently asked questions

What is FDA product code CJN?

CJN is the FDA product code for acid phosphatase, nitrophenylphosphate. It is a Class II device, regulated under 21 CFR 862.1020 and reviewed by the Clinical Chemistry panel.

What device class is CJN?

Class II, regulation 21 CFR 862.1020. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 36 days from receipt to decision (median 36).

Which companies have the most CJN clearances?

Sclavo, Inc. (1).

Next steps

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