Medical Device Manufacturer · SE , Solna

Ab Biodisk - FDA 510(k) Cleared Devices

64 submissions · 64 cleared · Since 1991

Recent clearances: ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML, ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA, DAPTOMYCIN

64

Total

64

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ab Biodisk Microbiology ✕

64 devices

1-12 of 64

Cleared Jul 24, 2008

ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML

Microbiology · 73d

Cleared Oct 13, 2005

ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA,...

Microbiology · 45d

Cleared Dec 13, 2004

Microbiology · 102d

Cleared Nov 19, 2004

ETEST FOR GEMIFLOXACIN

Microbiology · 78d

Cleared Jul 27, 2004

ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING

Microbiology · 146d

Cleared Jun 06, 2002

ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

Microbiology · 31d

Cleared Apr 29, 2002

ETEST ERTAPENEM

Microbiology · 53d

Cleared Apr 09, 2001

ETEST MEROPENEM

Microbiology · 61d

Cleared Nov 08, 2000

ETEST LINEZOLID

Microbiology · 114d

Cleared Aug 07, 2000

ETEST ESBL CT/CTL STRIP

Microbiology · 81d

Cleared May 22, 2000

ETEST GATIFLOXACIN

Microbiology · 90d

Cleared May 18, 2000

ETEST MOXIFLOXACIN

Microbiology · 108d

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