510(k) K100304
K100304 is an FDA 510(k) premarket notification submitted by Tosoh Bioscience, Inc. for the device "ST AIA PACK HBA1C". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Tosoh Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2010
- Date Received
- February 3, 2010
- 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