The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Campylobacter Chek.
| Device ID | K191442 |
| 510k Number | K191442 |
| Device Name: | Campylobacter Chek |
| Classification | Campylobacter Spp. |
| Applicant | Techlab, Inc. 2001 Kraft Drive Blacksburg, VA 24085 |
| Contact | Donna Link |
| Correspondent | Donna Link Techlab, Inc. 2001 Kraft Drive Blacksburg, VA 24085 |
| Product Code | LQP |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-30 |
| Decision Date | 2019-06-20 |