Technozym ADAMTS13 Activity
FDA 510(k) clearance DEN230024 · decided 2024-02-28
Clearance details
- K-number
- DEN230024
- Device name
- Technozym ADAMTS13 Activity
- Applicant
- Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM
- Decision
- Unknown
- Date received
- 2023-04-06
- Decision date
- 2024-02-28
- Days to decision
- 328 days
- Clearance type
- Direct
- Product code
- SAC
- Device class
- 2
- Regulation number
- 864.7297
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Vienna, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.