The following data is part of a premarket notification filed by Biotech Atlantic, Inc. with the FDA for Unistep Hcg Pregnancy Test Strip.
| Device ID | K941090 |
| 510k Number | K941090 |
| Device Name: | UNISTEP HCG PREGNANCY TEST STRIP |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST Eatontown, NJ 07724 |
| Contact | Yo Yih |
| Correspondent | Yo Yih BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST Eatontown, NJ 07724 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-08 |
| Decision Date | 1994-06-02 |