The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign H. Pylori Wb-new One-step Anti-h. Pylori Antibody Test.
| Device ID | K980798 |
| 510k Number | K980798 |
| Device Name: | BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST |
| Classification | Helicobacter Pylori |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang, Ph.d. |
| Correspondent | Jemo Kang, Ph.d. PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | LYR |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855574005414 | K980798 | 000 |