The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Crithidia Luciliae Native Dna-ifa Test.
| Device ID | K810301 |
| 510k Number | K810301 |
| Device Name: | CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IMMUNO CONCEPTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-04 |
| Decision Date | 1981-02-25 |