510(k) K792575

BACTEC BACTERIAL DETECTION SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1979
Date Received
December 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Microbial Growth
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type