510(k) K150226
K150226 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "Hematocrit and Metabolite QUALICHECK". The FDA issued a decision of Substantially Equivalent on May 13, 2015. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Radiometer Medical Aps has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2015
- Date Received
- February 2, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controls For Blood-Gases, (Assayed And Unassayed)
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type