HEPTRAC ELECTRONIC QUALITY CONTROL
FDA 510(k) clearance K981815 · decided 1998-07-30
Clearance details
- K-number
- K981815
- Device name
- HEPTRAC ELECTRONIC QUALITY CONTROL
- Applicant
- Medtronic Blood Management
- Decision
- Substantially Equivalent
- Date received
- 1998-05-22
- Decision date
- 1998-07-30
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Parker, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.