FACTOR VIII REFERENCE PLASMA — Helena Laboratories (510(k) K880292)
FACTOR VIII REFERENCE PLASMA — Helena Laboratories (510(k) K880292) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: FACTOR VIII REFERENCE PLASMA; Applicant: Helena Laboratories; Clearance track: 510(k).
| Device name | FACTOR VIII REFERENCE PLASMA |
|---|---|
| Applicant | Helena Laboratories |
| Clearance track | 510(k) |
| Submission number | K880292 |
| Decision | Substantially Equivalent |
| Decision date | 1988-02-19 |
| Date received | 1988-01-25 |
| Product code | GJT |
| Device class | 2 |
| Medical specialty | Hematology |
| Applicant location | TX, US |
| Source | openFDA device |
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$1999/mo
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