The following data is part of a premarket notification filed by Phoenix Biotech Corp. with the FDA for Trep-sure Treponemal Antibody Eia.
| Device ID | K053570 |
| 510k Number | K053570 |
| Device Name: | TREP-SURE TREPONEMAL ANTIBODY EIA |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | PHOENIX BIOTECH CORP. 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus PHOENIX BIOTECH CORP. 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-22 |
| Decision Date | 2006-08-07 |