FDA Device Explorer

Immunology (IM) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Immunology (IM) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 862, Part 864, Part 866

Subparts

• Part 862 Subpart C—Clinical Laboratory Instruments — 1 product code
• Part 864 Subpart B—Biological Stains — 1 product code
• Part 866 Subpart D—Serological Reagents — 5 product codes
• De Novo Classifications — 3 product codes
• Part 866 Subpart E—Immunology Laboratory Equipment and Reagents — 14 product codes
• Part 866 Subpart F—Immunological Test Systems — 240 product codes
• Part 866 Subpart G—Tumor Associated Antigen Immunological Test Systems — 25 product codes

Product Codes