The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Hcg-one Step Pregnancy Test, Accusign Hcg-one Step Pregnancy Test, Lifesign Hcg-one Step Pregnancy Test.
| Device ID | K974425 |
| 510k Number | K974425 |
| Device Name: | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-24 |
| Decision Date | 1997-12-24 |