510(k) K770185
K770185 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "RH CONTROL DILUENT". The FDA issued a decision of Substantially Equivalent on March 14, 1977. The device falls under product code KSZ (System, Test, Automated Blood Grouping And Antibody), a Class II device regulated under 21 CFR 864.9175. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1977
- Date Received
- January 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Automated Blood Grouping And Antibody
- Device Class
- Class II
- Regulation Number
- 864.9175
- Review Panel
- HE
- Submission Type