Medical Device Manufacturer · US , Westlake , OH

Trek Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

56 submissions · 56 cleared · Since 1998
56
Total
56
Cleared
0
Denied
56 devices
26-50 of 56
Cleared Mar 17, 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · LTT
Microbiology · 77d
Cleared Mar 06, 2003
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K024353 · LTT
Microbiology · 66d
Cleared Oct 08, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022656 · JWY
Microbiology · 60d
Cleared Sep 25, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021997 · JWY
Microbiology · 98d
Cleared Sep 25, 2002
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K022775 · JWY
Microbiology · 47d
Cleared Jun 20, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K021627 · JWY
Microbiology · 34d
Cleared May 15, 2002
CEFOTAXIME
K020859 · JWY
Microbiology · 58d
Cleared May 09, 2002
GATIFLOXIN
K020762 · JWY
Microbiology · 63d
Cleared May 09, 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K021339 · JWY
Microbiology · 63d
Cleared Mar 26, 2002
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014259 · JWY
Microbiology · 90d
Cleared Feb 19, 2002
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K014258 · JWY
Microbiology · 55d
Cleared Dec 21, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATES
K013925 · JWY
Microbiology · 37d
Cleared Dec 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE
K013580 · JWY
Microbiology · 44d
Cleared Nov 26, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013075 · JWY
Microbiology · 73d
Cleared Nov 20, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013368 · LTT
Microbiology · 40d
Cleared Nov 07, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
K013195 · LTT
Microbiology · 43d
Cleared Nov 02, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012921 · JWY
Microbiology · 63d
Cleared Oct 30, 2001
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K012895 · JWY
Microbiology · 63d
Cleared Oct 09, 2001
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
K991810 · NGZ
Microbiology · 866d
Cleared Sep 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012565 · JWY
Microbiology · 34d
Cleared Aug 29, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012151 · JWY
Microbiology · 50d
Cleared Aug 15, 2001
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
K011803 · JWY
Microbiology · 65d
Cleared Mar 06, 2001
SUSCEPTIBILITY TEST PANEL
K004045 · JWY
Microbiology · 67d
Cleared Feb 27, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868 · JWY
Microbiology · 75d
Cleared Feb 23, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003834 · JWY
Microbiology · 73d
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