510(k) K830363

BACTEC 170 TRYPTIC SOY BROTH W/RESINS by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LJF

K830363 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BACTEC 170 TRYPTIC SOY BROTH W/RESINS". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code LJF (Device, Antimicrobial Drug Removal), a Class I device regulated under 21 CFR 866.2560. 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 24, 1983
Date Received
February 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Antimicrobial Drug Removal
Device Class
Class I
Regulation Number
866.2560
Review Panel
MI
Submission Type