FDA product code GOY: Antisera, Agglutinating, B. Pertussis, All

GOY is the FDA product code for antisera, agglutinating, b. pertussis, all. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under GOY. The average 510(k) review took 54 days (median 54). FDA has posted 1 recall for GOY devices.

Classification

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

Top GOY applicants

Most recent GOY clearances

Recalls for GOY devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-07-23.

Frequently asked questions

What is FDA product code GOY?

GOY is the FDA product code for antisera, agglutinating, b. pertussis, all. It is a Class I device, regulated under 21 CFR 866.3065 and reviewed by the Microbiology panel.

What device class is GOY?

Class I, regulation 21 CFR 866.3065. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 54 days from receipt to decision (median 54).

Which companies have the most GOY clearances?

Absorbent Cotton Co., Inc. (1).

Have GOY devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2020-07-23.

Next steps

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

All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times