GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST — Ortho Diagnostic Systems, Inc. (510(k) K872628)
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST — Ortho Diagnostic Systems, Inc. (510(k) K872628) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST; Applicant: Ortho Diagnostic Systems, Inc.; Clearance track: 510(k).
| Device name | GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST |
|---|---|
| Applicant | Ortho Diagnostic Systems, Inc. |
| Clearance track | 510(k) |
| Submission number | K872628 |
| Decision | Substantially Equivalent |
| Decision date | 1987-12-21 |
| Date received | 1987-07-06 |
| Product code | LSL |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | NJ, US |
| Source | openFDA device |
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$1999/mo
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