The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Pathfinder(tm) Direct Antigen Detection System.
| Device ID | K863681 |
| 510k Number | K863681 |
| Device Name: | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| 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 | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-19 |
| Decision Date | 1986-12-03 |