The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Visual Hcg Pregnancy Test.
| Device ID | K923376 |
| 510k Number | K923376 |
| Device Name: | VISUAL HCG PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | TECH-CO, INC. 1856 STAR-BATT DR. Rochester Hills, MI 48309 |
| Contact | Chen |
| Correspondent | Chen TECH-CO, INC. 1856 STAR-BATT DR. Rochester Hills, MI 48309 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-09 |
| Decision Date | 1992-10-01 |