510(k) K053411
K053411 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS". The FDA issued a decision of Substantially Equivalent on February 3, 2006. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Microgenics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2006
- Date Received
- December 7, 2005
- 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