The following data is part of a premarket notification filed by Biotech Atlantic, Inc. with the FDA for Unimark Home Pregnancy Test Device.
| Device ID | K032992 |
| 510k Number | K032992 |
| Device Name: | UNIMARK HOME PREGNANCY TEST DEVICE |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST Eatontown, NJ 07724 |
| Contact | Francis L Deng |
| Correspondent | Francis L Deng BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST Eatontown, NJ 07724 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-25 |
| Decision Date | 2003-11-21 |
| Summary: | summary |