The following data is part of a premarket notification filed by Immuno-products Industries with the FDA for Antimitochondrial Immunofluorescent Test.
| Device ID | K810984 |
| 510k Number | K810984 |
| Device Name: | ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IMMUNO-PRODUCTS INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-13 |
| Decision Date | 1981-05-01 |