510(k) K123785
K123785 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET". The FDA issued a decision of Substantially Equivalent on June 7, 2013. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Diazyme Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2013
- Date Received
- December 10, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Myoglobin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5680
- Review Panel
- IM
- Submission Type