MULTIPLATE 5.0 AGGREGOMETER
FDA 510(k) clearance K103555 · decided 2012-07-27
Clearance details
- K-number
- K103555
- Device name
- MULTIPLATE 5.0 AGGREGOMETER
- Applicant
- Verum Diagnostica GmbH
- Decision
- Substantially Equivalent
- Date received
- 2010-12-03
- Decision date
- 2012-07-27
- Days to decision
- 602 days
- Clearance type
- Traditional
- Product code
- JOZ
- Device class
- 2
- Regulation number
- 864.5700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Munich, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.