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 May 09, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME
K020820
Dade Behring, Inc.
Microbiology · 57d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339
Trek Diagnostic Systems, Inc.
Microbiology · 63d
Cleared May 08, 2002
MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN
K020822
Dade Behring, Inc.
Microbiology · 56d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID
K020937
Dade Microscan, Inc.
Microbiology · 45d
Cleared May 06, 2002
MICROSTREP PLUS PANEL WITH AMPICILLIN
K021037
Dade Behring, Inc.
Microbiology · 35d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHOPRIM/SULFAMETHOXAZOLE
K020686
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 30, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR
K020691
Dade Microscan, Inc.
Microbiology · 57d
Cleared Apr 29, 2002
ETEST ERTAPENEM
K020748
Ab Biodisk
Microbiology · 53d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
K020556
Dade Microscan, Inc.
Microbiology · 65d
Cleared Mar 26, 2002
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014259
Trek Diagnostic Systems, Inc.
Microbiology · 90d
Cleared Mar 22, 2002
DRIED GRAM NEGATIVE MIC/COMBO PANELS
K020037
Dade Microscan, Inc.
Microbiology · 77d
Cleared Mar 20, 2002
PASCO MIC AND MIC/ID PANELS
K020331
Pasco Laboratories, Inc.
Microbiology · 48d
Cleared Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
K020162
Dade Behring, Inc.
Microbiology · 56d
Cleared Feb 19, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014258
Trek Diagnostic Systems, Inc.
Microbiology · 55d
Cleared Dec 21, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
K013925
Trek Diagnostic Systems, Inc.
Microbiology · 37d
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