The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Fertitell Direct Pregnancy Test #1100.
| Device ID | K832557 |
| 510k Number | K832557 |
| Device Name: | FERTITELL DIRECT PREGNANCY TEST #1100 |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-01 |
| Decision Date | 1983-09-12 |