Cleared Traditional

SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)

K983244 · Trek Diagnostic Systems, Inc. · Microbiology
Nov 1998
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K983244 is an FDA 510(k) clearance for the SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM), a System, Transport, Aerobic (Class I — General Controls, product code JTW), submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on November 30, 1998, 75 days after receiving the submission on September 16, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K983244 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1998
Decision Date November 30, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JTW — System, Transport, Aerobic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

Similar Devices — JTW System, Transport, Aerobic

All 42
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
K121039 · Copan Flock Technologies · May 2012
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
K061301 · Copan Diagnostics, Inc. · Jun 2006
GEN-PROBE APTIMA COMBO 2 ASSAY
K022874 · Gen-Probe, Inc. · Sep 2002
URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM
K013819 · Sierra Diagnostic, LLC · Feb 2002
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
K993161 · Copan Diagnostics, Inc. · Nov 1999
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
K961148 · Difco Laboratories, Inc. · Apr 1996