Cleared Traditional

SYNERCID, 15 UG, BBL SENSI-DISC

K993186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Nov 1999
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K993186 is an FDA 510(k) clearance for the SYNERCID, 15 UG, BBL SENSI-DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on November 3, 1999, 42 days after receiving the submission on September 22, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K993186 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1999
Decision Date November 03, 1999
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1620

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