The following data is part of a premarket notification filed by Techlab, Inc. with the FDA for H. Pylori Chek™.
| Device ID | K181400 |
| 510k Number | K181400 |
| Device Name: | H. PYLORI CHEK™ |
| Classification | Helicobacter Pylori |
| Applicant | TECHLAB, Inc. 2001 Kraft Drive Corporate Research Center Blacksburg, VA 24060 |
| Contact | Donna T. Link |
| Correspondent | Donna T. Link TECHLAB, Inc. 2001 Kraft Drive Corporate Research Center Blacksburg, VA 24060 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-29 |
| Decision Date | 2018-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857031002523 | K181400 | 000 |
| 00857031002509 | K181400 | 000 |
| 00857031002639 | K181400 | 000 |