The following data is part of a premarket notification filed by Natureplex, Llc with the FDA for Be-certain Pregnancy Test.
| Device ID | K051963 |
| 510k Number | K051963 |
| Device Name: | BE-CERTAIN PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | NATUREPLEX, LLC 3791 AIRPARK ST. Memphis, TN 38118 |
| Contact | Victor J Santos |
| Correspondent | Victor J Santos NATUREPLEX, LLC 3791 AIRPARK ST. Memphis, TN 38118 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-19 |
| Decision Date | 2005-11-23 |
| Summary: | summary |