ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 — Helena Laboratories (510(k) K020914)
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 — Helena Laboratories (510(k) K020914) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770; Applicant: Helena Laboratories; Clearance track: 510(k).
| Device name | ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 |
|---|---|
| Applicant | Helena Laboratories |
| Clearance track | 510(k) |
| Submission number | K020914 |
| Decision | Substantially Equivalent |
| Decision date | 2002-05-23 |
| Date received | 2002-03-21 |
| Product code | JBP |
| Device class | 2 |
| Medical specialty | Hematology |
| Applicant location | TX, US |
| Source | openFDA device |
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$1999/mo
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