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
145–168 of 441
Cleared Jun 17, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
K021181
Dade Microscan, Inc.
Microbiology · 63d
Cleared Jun 11, 2002
MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
K021018
Dade Microscan, Inc.
Microbiology · 74d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
K021110
Dade Microscan, Inc.
Microbiology · 62d
Cleared Jun 06, 2002
MICROSTREP PLUS PANEL, AZITHROMYCIN
K021169
Dade Microscan, Inc.
Microbiology · 56d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
K021188
Dade Microscan, Inc.
Microbiology · 52d
Cleared Jun 06, 2002
ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
K021445
Ab Biodisk
Microbiology · 31d
Cleared Jun 03, 2002
MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
K020938
Dade Microscan, Inc.
Microbiology · 73d
Cleared May 15, 2002
CEFOTAXIME
K020859
Trek Diagnostic Systems, Inc.
Microbiology · 58d
Cleared May 09, 2002
GATIFLOXIN
K020762
Trek Diagnostic Systems, Inc.
Microbiology · 63d
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