IMMUNODOT LYME TEST — General Biometrics, Inc. (510(k) K894410)
IMMUNODOT LYME TEST — General Biometrics, Inc. (510(k) K894410) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: IMMUNODOT LYME TEST; Applicant: General Biometrics, Inc.; Clearance track: 510(k).
| Device name | IMMUNODOT LYME TEST |
|---|---|
| Applicant | General Biometrics, Inc. |
| Clearance track | 510(k) |
| Submission number | K894410 |
| Decision | Substantially Equivalent |
| Decision date | 1989-10-30 |
| Date received | 1989-07-17 |
| Product code | LSR |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | CA, US |
| Source | openFDA device |
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$1999/mo
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