510(k) K141944
K141944 is an FDA 510(k) premarket notification submitted by Home Access Health Corp. for the device "HOME ACCESS AIC TEST". The FDA issued a decision of Substantially Equivalent on March 13, 2015. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Home Access Health Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2015
- Date Received
- July 17, 2014
- 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