510(k) K031296
K031296 is an FDA 510(k) premarket notification submitted by Biodiagnostic Intl for the device "LIQUI-HEME GLYCO A1C ASSAY". The FDA issued a decision of Substantially Equivalent on October 15, 2004. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Biodiagnostic Intl has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2004
- Date Received
- April 23, 2003
- 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