510(k) K122553
K122553 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 5, 2013. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 2013
- Date Received
- August 21, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Hemoglobin, Automated
- Device Class
- Class II
- Regulation Number
- 864.5620
- Review Panel
- HE
- Submission Type