The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biostrip Hcg I-one Step Pregnancy Test Accustrip Hcg 1-one Step Pregnancy Test Strip.
| Device ID | K981444 |
| 510k Number | K981444 |
| Device Name: | BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| 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 | 1998-07-22 |