FDA product code DDY: Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control

DDY is the FDA product code for alpha-2-macroglobulin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5620 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DDY. The average 510(k) review took 113 days (median 113).

Classification

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

Top DDY applicants

Most recent DDY clearances

Recalls for DDY devices

openFDA lists no recalls for product code DDY.

Frequently asked questions

What is FDA product code DDY?

DDY is the FDA product code for alpha-2-macroglobulin, fitc, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5620 and reviewed by the Immunology panel.

What device class is DDY?

Class II, regulation 21 CFR 866.5620. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 113 days from receipt to decision (median 113).

Which companies have the most DDY clearances?

Kent Laboratories, Inc. (1).

Next steps

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