Cleared Traditional

CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC

K993577 · Becton Dickinson Microbiology Systems · Microbiology
Dec 1999
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K993577 is an FDA 510(k) clearance for the CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Becton Dickinson Microbiology Systems (Sparks, US). The FDA issued a Cleared decision on December 1, 1999, 41 days after receiving the submission on October 21, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K993577 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 1999
Decision Date December 01, 1999
Days to Decision 41 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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