STREPTEX DIRECT A ZL14 — Wellcome Diagnostics (510(k) K842827)
STREPTEX DIRECT A ZL14 — Wellcome Diagnostics (510(k) K842827) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: STREPTEX DIRECT A ZL14; Applicant: Wellcome Diagnostics; Clearance track: 510(k).
| Device name | STREPTEX DIRECT A ZL14 |
|---|---|
| Applicant | Wellcome Diagnostics |
| Clearance track | 510(k) |
| Submission number | K842827 |
| Decision | Substantially Equivalent |
| Decision date | 1984-08-16 |
| Date received | 1984-07-20 |
| Product code | GTZ |
| Device class | 1 |
| Medical specialty | Microbiology |
| Applicant location | IL, US |
| Source | openFDA device |
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$1999/mo
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