JWY · Class II · 21 CFR 866.1640

FDA Product Code JWY: Manual Antimicrobial Susceptibility Test Systems

FDA product code JWY covers manual antimicrobial susceptibility test systems.

These diagnostic systems are used to determine which antibiotics are effective against specific bacterial or fungal isolates from patient samples. Results guide clinicians in selecting appropriate antibiotic therapy, a critical step in managing infections and combating antimicrobial resistance.

JWY devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.

Leading manufacturers include Ab Biodisk, Thermo Fisher Scientific and Trek Diagnostic Systems, Inc..

441
Total
441
Cleared
89d
Avg days
1981
Since
441 devices
121–144 of 441
Cleared Nov 09, 2006
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062839
Trek Diagnostic Systems, Inc.
Microbiology · 49d
Cleared Nov 01, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062816
Trek Diagnostic Systems, Inc.
Microbiology · 42d
Cleared Oct 26, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062783
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 20, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062722
Trek Diagnostic Systems, Inc.
Microbiology · 38d
Cleared Oct 13, 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062681
Trek Diagnostic Systems, Ltd.
Microbiology · 35d
Cleared Sep 11, 2006
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062022
Trek Diagnostic Systems, Inc.
Microbiology · 56d
Cleared Aug 31, 2006
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K062190
Trek Diagnostic Systems, Inc.
Microbiology · 31d
Cleared Jul 21, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061687
Dade Behring, Inc.
Microbiology · 36d
Cleared Jul 18, 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061536
Dade Behring, Inc.
Microbiology · 46d
Cleared May 16, 2006
SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
K060783
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared Apr 21, 2006
SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
K060621
Tds Holdings, Inc.
Microbiology · 44d
Cleared Oct 13, 2005
ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
K052366
Ab Biodisk
Microbiology · 45d
Cleared Sep 21, 2005
SENSITIRE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K052091
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Jun 23, 2005
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K051202
Dade Behring, Inc.
Microbiology · 43d
Cleared Feb 14, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
K043589
Dade Microscan, Inc.
Microbiology · 48d
Cleared Dec 13, 2004
DAPTOMYCIN
K042392
Ab Biodisk
Microbiology · 102d
Cleared Nov 19, 2004
ETEST FOR GEMIFLOXACIN
K042390
Ab Biodisk
Microbiology · 78d
Cleared Oct 07, 2004
PASCO MIC AND MIC/ID PANELS
K042331
Pasco Laboratories, Inc.
Microbiology · 38d
Cleared Aug 03, 2004
PASCO MIC AND MIC/ID PANELS
K041776
Pasco Laboratories, Inc.
Microbiology · 33d
Cleared Jul 27, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL
K041534
Trek Diagnostic Systems, Ltd.
Microbiology · 49d
Cleared Jun 07, 2004
PASCO MIC AND MIC/ID PANELS
K041214
Pasco Laboratories, Inc.
Microbiology · 28d
Cleared Apr 26, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040846
Trek Diagnostic Systems, Inc.
Microbiology · 25d
Cleared Apr 07, 2004
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K040619
Trek Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Feb 10, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
K032706
Dade Behring, Inc.
Microbiology · 161d