The following data is part of a premarket notification filed by Williams, The J.b. Co., Inc. with the FDA for Acu-test In-home Pregnancy Test.
| Device ID | K781049 |
| 510k Number | K781049 |
| Device Name: | ACU-TEST IN-HOME PREGNANCY TEST |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | WILLIAMS, THE J.B. CO., INC. 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 | 1978-06-22 |
| Decision Date | 1978-06-29 |