The following data is part of a premarket notification filed by Scripps-miles, Inc. with the FDA for Hep-2-crithidia Luciliae Ana Test Kit.
| Device ID | K811714 |
| 510k Number | K811714 |
| Device Name: | HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | SCRIPPS-MILES, 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 | 1981-06-17 |
| Decision Date | 1981-07-10 |