The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Pathfinder Direct Antigen Detection Sys Rotavirus.
| Device ID | K853554 |
| 510k Number | K853554 |
| Device Name: | PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| 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 | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-26 |
| Decision Date | 1985-11-26 |