510(k) K770980

EMATOLOGY DILUENT RESERVOIR CLOSURE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code GHO

K770980 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "EMATOLOGY DILUENT RESERVOIR CLOSURE". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code GHO (Hemocytometer), a Class I device regulated under 21 CFR 864.6160. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1977
Date Received
May 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemocytometer
Device Class
Class I
Regulation Number
864.6160
Review Panel
HE
Submission Type