510(k) K163215
K163215 is an FDA 510(k) premarket notification submitted by Sanguina, LLC for the device "AnemoCheck". The FDA issued a decision of Substantially Equivalent on September 13, 2017. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Sanguina, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2017
- Date Received
- November 16, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Blood Hemoglobin Determination
- Device Class
- Class II
- Regulation Number
- 864.7500
- Review Panel
- HE
- Submission Type