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
26-50 of 64
Cleared Oct 02, 1998
TRIMETHOPRIM/SULPHAMETHOXAZOLE
K983027 · JWY
Microbiology · 32d
Cleared Sep 30, 1998
ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE
K982868 · JWY
Microbiology · 47d
Cleared Sep 03, 1998
SYSTEM U3 FOR CIPROFLOXACIN
K981639 · JWY
Microbiology · 118d
Cleared Jul 06, 1998
ETEST CEFDINIR
K980877 · JWY
Microbiology · 119d
Cleared Jun 15, 1998
ETEST BENZYLPENICILLIN
K980335 · JWY
Microbiology · 138d
Cleared Jun 09, 1998
ETEST BENZYLPENICILLIN
K981135 · JWY
Microbiology · 71d
Cleared Jun 09, 1998
ETEST FOSFOMYCIN
K981136 · JWY
Microbiology · 71d
Cleared Jun 09, 1998
ETEST CEFOTAXIME
K981137 · JWY
Microbiology · 71d
Cleared Jun 05, 1998
ETEST CIPROFLOXACIN
K981138 · JWY
Microbiology · 67d
Cleared Jun 01, 1998
ETEST CEFTRIAXONE
K981139 · JWY
Microbiology · 63d
Cleared May 29, 1998
ETEST CHLORAMPHENICAL
K980342 · JWY
Microbiology · 121d
Cleared May 29, 1998
ETEST VANCOMYCIN
K980348 · JWY
Microbiology · 121d
Cleared May 28, 1998
ETEST OFLOXACIN
K980338 · JWY
Microbiology · 120d
Cleared May 28, 1998
ETEST TETRACYCLINE
K981134 · JWY
Microbiology · 59d
Cleared May 27, 1998
ETEST CEFTRIAXONE
K980345 · JWY
Microbiology · 118d
Cleared May 27, 1998
ETEST TETRACYCLINE
K980347 · JWY
Microbiology · 119d
Cleared May 18, 1998
ETEST GREPAFLOXACIN
K980773 · JWY
Microbiology · 77d
Cleared May 13, 1998
ETEST TROVAFLOXACIN
K980603 · JWY
Microbiology · 85d
Cleared Jul 14, 1997
ETEST FOR LEVOFLOXACIN
K971697 · JWY
Microbiology · 67d
Cleared Jun 30, 1997
ETEST FOR CEFTAZIDIME
K971694 · JWY
Microbiology · 54d
Cleared May 01, 1997
(MODIFIED) ETEST PACKAGE INSERT
K964236 · JWY
Microbiology · 195d
Cleared May 01, 1997
AMIKACIN
K970210 · JWY
Microbiology · 100d
Cleared May 01, 1997
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
K970473 · JWY
Microbiology · 83d
Cleared Apr 25, 1997
ETEST SPARFLOXACIN
K970820 · JWY
Microbiology · 50d
Cleared Dec 18, 1996
PIPERACILLIN/TAZOBACTAM 4
K964203 · JWY
Microbiology · 77d
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