The following data is part of a premarket notification filed by Lia Diagnostics with the FDA for Lia Pregnancy Test.
| Device ID | K171136 |
| 510k Number | K171136 |
| Device Name: | LIA Pregnancy Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | LIA Diagnostics 1015 Chestnut St Suite 1401 Philadelphia, PA 19107 |
| Contact | Anna Couturier |
| Correspondent | Anna Couturier LIA Diagnostics 1015 Chestnut St Suite 1401 Philadelphia, PA 19107 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-17 |
| Decision Date | 2017-11-20 |
| Summary: | summary |