510(k) K800037
K800037 is an FDA 510(k) premarket notification submitted by Hemometrix for the device "PLATELET RETENTION (ADHESION) COLUMNS". The FDA issued a decision of Substantially Equivalent on February 5, 1980. The device falls under product code JBZ (Study, Platelet Adhesive), a Class II device regulated under 21 CFR 864.6650. Hemometrix has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1980
- Date Received
- January 7, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Study, Platelet Adhesive
- Device Class
- Class II
- Regulation Number
- 864.6650
- Review Panel
- HE
- Submission Type