The following data is part of a premarket notification filed by Trinity Biotech with the FDA for Lyme B. Burgdorferi (igg) Marstripe Test.
| Device ID | K163095 |
| 510k Number | K163095 |
| Device Name: | Lyme B. Burgdorferi (IgG) MarStripe Test |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | Trinity Biotech 60 Pineview Dr. Buffalo, NY 14031 |
| Contact | Kevin Lawson |
| Correspondent | Kevin Lawson Trinity Biotech 60 Pineview Dr. Buffalo, NY 14031 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-04 |
| Decision Date | 2017-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845714004728 | K163095 | 000 |
| 00845714004711 | K163095 | 000 |
| 00845714004704 | K163095 | 000 |