The following data is part of a premarket notification filed by Trinity Biotech Usa with the FDA for Borrelia Burgdorferi Igm Elisa Test System.
| Device ID | K033070 |
| 510k Number | K033070 |
| Device Name: | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | TRINITY BIOTECH USA P.O. BOX 1059 Jamestown, NY 14702 -1059 |
| Contact | Bonnie B Dejoy |
| Correspondent | Bonnie B Dejoy TRINITY BIOTECH USA P.O. BOX 1059 Jamestown, NY 14702 -1059 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-11-26 |
| Summary: | summary |