Cleared Traditional

SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K982523 · Oxoid , Ltd. · Microbiology
Sep 1998
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K982523 is an FDA 510(k) clearance for the SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC, a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on September 9, 1998, 51 days after receiving the submission on July 20, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K982523 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1998
Decision Date September 09, 1998
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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