FDA product code JBY: Aggregometer, Platelet, Photo-Optical Scanning

JBY is the FDA product code for aggregometer, platelet, photo-optical scanning. It is a Class II device, regulated under 21 CFR 864.6675 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under JBY, from 2 different applicants. The average 510(k) review took 60 days (median 60).

Classification

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

Top JBY applicants

Most recent JBY clearances

Recalls for JBY devices

openFDA lists no recalls for product code JBY.

Frequently asked questions

What is FDA product code JBY?

JBY is the FDA product code for aggregometer, platelet, photo-optical scanning. It is a Class II device, regulated under 21 CFR 864.6675 and reviewed by the Hematology panel.

What device class is JBY?

Class II, regulation 21 CFR 864.6675. Typical premarket route: 510(k).

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

Across 2 cleared submissions the average was 60 days from receipt to decision (median 60).

Which companies have the most JBY clearances?

Helena Laboratories (1); Chrono-Log Corp. (1).

Next steps

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