510(k) K111128
K111128 is an FDA 510(k) premarket notification submitted by Ceragem International, Inc. for the device "LABONACHECK A1C". The FDA issued a decision of Substantially Equivalent on September 13, 2012. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Ceragem International, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2012
- Date Received
- April 21, 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