Cleared Traditional

K983301: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN

K983301 · Accumed Intl., Inc. · Microbiology
Nov 1998
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K983301 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH TROVAFLOXACIN, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on November 25, 1998, 65 days after receiving the submission on September 21, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K983301 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1998
Decision Date November 25, 1998
Days to Decision 65 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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