The following data is part of a premarket notification filed by Yd Diagnostics with the FDA for Preg-q Early Pregnancy Test.
| Device ID | K023027 |
| 510k Number | K023027 |
| Device Name: | PREG-Q EARLY PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | YD DIAGNOSTICS 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Beach |
| Correspondent | Art Beach YD DIAGNOSTICS 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-11 |
| Decision Date | 2002-12-16 |
| Summary: | summary |