The following data is part of a premarket notification filed by Biotech Atlantic, Inc. with the FDA for Unimark Midstream Pregnancy Test Stick.
| Device ID | K960174 |
| 510k Number | K960174 |
| Device Name: | UNIMARK MIDSTREAM PREGNANCY TEST STICK |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722355002873 | K960174 | 000 |
| 00722355002866 | K960174 | 000 |
| 00722355002859 | K960174 | 000 |
| 00722355002842 | K960174 | 000 |
| 20722355002884 | K960174 | 000 |