Cleared Traditional

CEFDINIR, 5 UG, SENSI-DISC

K981517 · Becton Dickinson Microbiology Systems · Microbiology
Jun 1998
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K981517 is an FDA 510(k) clearance for the CEFDINIR, 5 UG, 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 June 9, 1998, 42 days after receiving the submission on April 28, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K981517 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1998
Decision Date June 09, 1998
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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