The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Kallestad Ssa/ssb Ena Test Reagents.
| Device ID | K862710 |
| 510k Number | K862710 |
| Device Name: | KALLESTAD SSA/SSB ENA TEST REAGENTS |
| Classification | Extractable Antinuclear Antibody, Antigen And Control |
| Applicant | KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Katia Breslawec |
| Correspondent | Katia Breslawec KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-16 |
| Decision Date | 1986-07-29 |