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
169–192 of 441
Cleared Dec 12, 2001
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS
K013423
Dade Microscan, Inc.
Microbiology · 71d
Cleared Dec 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
K013580
Trek Diagnostic Systems, Inc.
Microbiology · 44d
Cleared Nov 26, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013075
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Nov 02, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012921
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Oct 30, 2001
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K012895
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Sep 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012565
Trek Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Aug 29, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012151
Trek Diagnostic Systems, Inc.
Microbiology · 50d
Cleared Aug 15, 2001
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
K011803
Trek Diagnostic Systems, Inc.
Microbiology · 65d
Cleared Apr 09, 2001
ETEST MEROPENEM
K010363
Ab Biodisk
Microbiology · 61d
Cleared Mar 06, 2001
SUSCEPTIBILITY TEST PANEL
K004045
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Feb 27, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868
Trek Diagnostic Systems, Inc.
Microbiology · 75d
Cleared Feb 23, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003834
Trek Diagnostic Systems, Inc.
Microbiology · 73d
Cleared Aug 10, 2000
PASCO MIC AND MIC/ID PANELS
K001953
Pasco Laboratories, Inc.
Microbiology · 44d
Cleared Aug 09, 2000
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
K001887
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Aug 07, 2000
ETEST ESBL CT/CTL STRIP
K001547
Ab Biodisk
Microbiology · 81d
Cleared Jul 24, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
K001558
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Jul 18, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K001573
Trek Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Jul 18, 2000
PASCO MIC AND MIC/ID PANELS
K001612
Pasco Laboratories, Inc.
Microbiology · 54d
Cleared Jul 12, 2000
PASCO MIC AND MIC/ID PANELS
K001516
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jun 06, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
K001036
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared May 23, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
K001035
Trek Diagnostic Systems, Inc.
Microbiology · 53d
Cleared May 22, 2000
ETEST GATIFLOXACIN
K000596
Ab Biodisk
Microbiology · 90d
Cleared May 18, 2000
ETEST MOXIFLOXACIN
K000298
Ab Biodisk
Microbiology · 108d
Cleared Feb 18, 2000
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943
Dade Microscan, Inc.
Microbiology · 470d