The following data is part of a premarket notification filed by Biotech Atlantic, Inc. with the FDA for Unimark Hcg Combo Pregnancy Test.
| Device ID | K013194 |
| 510k Number | K013194 |
| Device Name: | UNIMARK HCG COMBO PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST Eatontown, NJ 07724 |
| Contact | Francis Lee |
| Correspondent | Francis Lee BIOTECH ATLANTIC, INC. BAY F, 6 INDUSTRIAL WAY WEST Eatontown, NJ 07724 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2001-10-10 |
| Summary: | summary |