510(k) K093548
K093548 is an FDA 510(k) premarket notification submitted by Mec Dynamics Corp for the device "AVIE A1C TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 20, 2011. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Mec Dynamics Corp has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2011
- Date Received
- November 17, 2009
- 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