510(k) K853011

BACTEC NR-730 BACTERIAL DETECTION SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1985
Date Received
July 16, 1985
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