The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Hcg I - One Step Pregnancy Test.
| Device ID | K981443 |
| 510k Number | K981443 |
| Device Name: | BIOSIGN HCG I - ONE STEP PREGNANCY TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-22 |
| Decision Date | 1998-06-25 |