BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM — Trinity Biotech USA (510(k) K033083)
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM — Trinity Biotech USA (510(k) K033083) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM; Applicant: Trinity Biotech USA; Clearance track: 510(k).
| Device name | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM |
|---|---|
| Applicant | Trinity Biotech USA |
| Clearance track | 510(k) |
| Submission number | K033083 |
| Decision | Substantially Equivalent |
| Decision date | 2003-11-26 |
| Date received | 2003-09-29 |
| Product code | LSR |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | NY, US |
| Source | openFDA device |
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$1999/mo
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