The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for Campylobacter Quik Chek.
| Device ID | K173217 |
| 510k Number | K173217 |
| Device Name: | CAMPYLOBACTER QUIK CHEK |
| Classification | Campylobacter Spp. |
| Applicant | Techlab, Inc. 2001 Kraft Drive Blacksburg, VA 24060 |
| Contact | Donna T. Link |
| Correspondent | Donna T. Link Techlab, Inc. 2001 Kraft Drive Blacksburg, VA 24060 |
| Product Code | LQP |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-03 |
| Decision Date | 2018-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002455 | K173217 | 000 |
| 00857031002479 | K173217 | 000 |
| 00857031002578 | K173217 | 000 |