The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Florescent Ana/ama/asma Test.
| Device ID | K792610 |
| 510k Number | K792610 |
| Device Name: | KALLESTAD FLORESCENT ANA/AMA/ASMA TEST |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | KALLESTAD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-12-18 |
| Decision Date | 1980-02-22 |