FDA product code JLP: Spectrophotometric Method, Pregnanediol

JLP is the FDA product code for spectrophotometric method, pregnanediol. It is a Class I device, regulated under 21 CFR 862.1605 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under JLP. The average 510(k) review took 197 days (median 197).

Classification

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

Top JLP applicants

Most recent JLP clearances

Recalls for JLP devices

openFDA lists no recalls for product code JLP.

Frequently asked questions

What is FDA product code JLP?

JLP is the FDA product code for spectrophotometric method, pregnanediol. It is a Class I device, regulated under 21 CFR 862.1605 and reviewed by the Clinical Chemistry panel.

What device class is JLP?

Class I, regulation 21 CFR 862.1605. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 197 days from receipt to decision (median 197).

Which companies have the most JLP clearances?

Boots-Celltech Diagnostics, Inc. (1).

Next steps

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