The following data is part of a premarket notification filed by Kallestad Diag, A Div. Of Erbamont, Inc. with the FDA for Pathfinder Chlamydia Culture Confirmation System.
| Device ID | K864663 |
| 510k Number | K864663 |
| Device Name: | PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Quinlan Smith |
| Correspondent | Quinlan Smith KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. 2000 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 | 1986-11-28 |
| Decision Date | 1987-02-02 |