AVIE TOTAL HB TEST SYSTEM
FDA 510(k) clearance K121752 · decided 2013-01-07
Clearance details
- K-number
- K121752
- Device name
- AVIE TOTAL HB TEST SYSTEM
- Applicant
- Mec Dynamics Corp
- Decision
- Substantially Equivalent
- Date received
- 2012-06-14
- Decision date
- 2013-01-07
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- GKR
- Device class
- 2
- Regulation number
- 864.5620
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.