The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Qupid Plus E.r..
| Device ID | K020378 |
| 510k Number | K020378 |
| Device Name: | QUPID PLUS E.R. |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne, TX 78006 |
| Contact | Kirk Johnson |
| Correspondent | Kirk Johnson STANBIO LABORATORY 1261 NORTH MAIN ST. Boerne, TX 78006 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-05 |
| Decision Date | 2002-06-21 |
| Summary: | summary |