The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Pathfinder(tm) Specimen Collection Kit.
| Device ID | K863682 |
| 510k Number | K863682 |
| Device Name: | PATHFINDER(TM) SPECIMEN COLLECTION KIT |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Quinlan Smith |
| Correspondent | Quinlan Smith KALLESTAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-19 |
| Decision Date | 1986-10-10 |