The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Status Hcg Serum/urine.
| Device ID | K020439 |
| 510k Number | K020439 |
| Device Name: | STATUS HCG SERUM/URINE |
| 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 | 2002-02-11 |
| Decision Date | 2002-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855574005384 | K020439 | 000 |
| 15099590625948 | K020439 | 000 |