The following data is part of a premarket notification filed by Spd Swiss Precision Diagnostics Gmbh with the FDA for One Step Pregnancy Test.
| Device ID | K210341 |
| 510k Number | K210341 |
| Device Name: | One Step Pregnancy Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SPD Swiss Precision Diagnostics GmbH 47 Route De Saint Georges, Petit-Lancy Geneva, CH Ch-1213 |
| Contact | Joanne Scaife |
| Correspondent | Kamila Przedmojska SPD Development Company Limited Priory Business Park, Stannard Way Bedford, GB Mk44 3up |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-05 |
| Decision Date | 2022-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10681131107225 | K210341 | 000 |
| 10751774013730 | K210341 | 000 |
| 10751774250784 | K210341 | 000 |
| 10041220549754 | K210341 | 000 |