510(k) K993186

SYNERCID, 15 UG, BBL SENSI-DISC by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code JTN

K993186 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "SYNERCID, 15 UG, BBL SENSI-DISC". The FDA issued a decision of Substantially Equivalent on November 3, 1999. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1999
Date Received
September 22, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type