510(k) K112015
K112015 is an FDA 510(k) premarket notification submitted by Primus Corporation Dba Trinity Biotech for the device "PREMIER HB9210 HBA1C ANALYZER". The FDA issued a decision of Substantially Equivalent on November 22, 2011. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 2011
- Date Received
- July 13, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Glycosylated Hemoglobin
- Device Class
- Class II
- Regulation Number
- 864.7470
- Review Panel
- HE
- Submission Type