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 |