The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Direct Pregnancy Test.
| Device ID | K920716 |
| 510k Number | K920716 |
| Device Name: | DIRECT PREGNANCY TEST |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| 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 | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-18 |
| Decision Date | 1992-03-24 |