The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Biostix (tm)hcg--simple Pregnancy Test.
| Device ID | K892654 |
| 510k Number | K892654 |
| Device Name: | BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | PRINCETON BIOMEDIX 24 B WORLDS FAIR DR. Somerset, NJ 08873 |
| Contact | Kang, Ph.d. |
| Correspondent | Kang, Ph.d. PRINCETON BIOMEDIX 24 B WORLDS FAIR DR. Somerset, NJ 08873 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-06-19 |