510(k) K012410
K012410 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "INFINITY HBA KIT, MODELS 537-A, 537-B". The FDA issued a decision of Substantially Equivalent on October 26, 2001. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2001
- Date Received
- July 30, 2001
- 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