The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biostrip(r) Hcg-one Step Pregnancy Test.
| Device ID | K950307 |
| 510k Number | K950307 |
| Device Name: | BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-25 |
| Decision Date | 1995-03-01 |