MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
FDA 510(k) clearance K122553 · decided 2013-08-05
Clearance details
- K-number
- K122553
- Device name
- MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-21
- Decision date
- 2013-08-05
- Days to decision
- 349 days
- Clearance type
- Traditional
- Product code
- GKR
- Device class
- 2
- Regulation number
- 864.5620
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.