The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Biosign Hcg-one Step Pregnancy Test.
| Device ID | K901011 |
| 510k Number | K901011 |
| Device Name: | BIOSIGN HCG-ONE STEP PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-05 |
| Decision Date | 1990-05-04 |