510(k) K770185

RH CONTROL DILUENT by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KSZ

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