Medical Device Manufacturer · SE , Solna

Ab Biodisk - FDA 510(k) Cleared Devices

64 submissions · 64 cleared · Since 1991

64

Total

64

Cleared

0

Denied

64 devices

51-64 of 64

Cleared Oct 24, 1996

ETEST FOR CEFEPIME

Microbiology · 73d

Cleared Oct 08, 1996

ETEST SUBMISSION FOR AMOXICILLIN

Microbiology · 211d

Cleared Aug 30, 1996

ETEST FOR AZTREONAM

Microbiology · 44d

Cleared Jul 05, 1996

ETEST SUBMISSION FOR CEFOTETAN

Microbiology · 74d

Cleared Jul 05, 1996

ETEST SUBMISSION FOR AZITHROMYCIN

Microbiology · 74d

Cleared May 20, 1996

ETEST SUBMISSION FOR IMIPENEM

Microbiology · 70d

Cleared May 20, 1996

ETEST SUBMISSION FOR VANCOMYCIN

Microbiology · 70d

Cleared Feb 22, 1996

THE E TEST CEFTIZOXIME

Microbiology · 113d

Cleared Dec 12, 1995

AMOXICILLIN/CLAVULANIC ACID 2/1

Microbiology · 90d

Cleared Aug 15, 1995

PIPERACILIN TAZOBACTAM 4 UG

Microbiology · 123d

Cleared Jul 07, 1995

TICARCILLIN/CLAVULANIC ACID 2

Microbiology · 84d

Cleared May 02, 1995

E TEST FOR OFLOXACIN

Microbiology · 134d

Cleared Mar 17, 1995

ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS

Microbiology · 144d

Cleared Sep 25, 1991

THE E TEST, MODIFICATION

Microbiology · 51d