ClearanceBrief
Company ยท SE

Ab Biodisk

FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2008. Name variants (Inc, Corp, punctuation) are merged.

64510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
JWYManual Antimicrobial Susceptibility Test Systems61
LTXDiscs, Elution2
NGZSusceptibility Test Plate, Antifungal1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 24, 2008K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
Ab Biodisk, SE
JWY
Oct 13, 2005K052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
Ab Biodisk, SE
JWY
Dec 13, 2004K042392DAPTOMYCIN
Ab Biodisk, SE
JWY
Nov 19, 2004K042390ETEST FOR GEMIFLOXACIN
Ab Biodisk, SE
JWY
Jul 27, 2004K040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
Ab Biodisk, SE
NGZ
Jun 6, 2002K021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
Ab Biodisk, SE
JWY
Apr 29, 2002K020748ETEST ERTAPENEM
Ab Biodisk, SE
JWY
Apr 9, 2001K010363ETEST MEROPENEM
Ab Biodisk, SE
JWY
Nov 8, 2000K002139ETEST LINEZOLID
Ab Biodisk, SE
LTX
Aug 7, 2000K001547ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP
Ab Biodisk, SE
JWY
May 22, 2000K000596ETEST GATIFLOXACIN
Ab Biodisk, SE
JWY
May 18, 2000K000298ETEST MOXIFLOXACIN
Ab Biodisk, SE
JWY
Nov 16, 1999K992993ETEST FOR QUINUPRISTIN/DALFOPRISTIN
Ab Biodisk, SE
LTX
Apr 22, 1999K990722ETEST FOR CEFUROXIME
Ab Biodisk, SE
JWY
Mar 26, 1999K990685TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
Ab Biodisk, SE
JWY
Mar 22, 1999K990297ETEST MINOCYCLINE
Ab Biodisk, SE
JWY
Mar 9, 1999K984581SYSTEM U3 FOR CEPHALOTHIN
Ab Biodisk, SE
JWY
Mar 9, 1999K984491SYSTEM U3 FOR CEFUROXIME
Ab Biodisk, SE
JWY
Feb 18, 1999K983890SYSTEM U3
Ab Biodisk, SE
JWY
Feb 9, 1999K984144SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID
Ab Biodisk, SE
JWY
Feb 8, 1999K984087SYSTEM U3 FOR AMPICILLIN
Ab Biodisk, SE
JWY
Jan 5, 1999K983565SYSTEM U3 FOR NITROFURANTOIN
Ab Biodisk, SE
JWY
Dec 30, 1998K983571SYSTEM U3 FOR TETRACYCLINE
Ab Biodisk, SE
JWY
Dec 23, 1998K983486SYSTEM U3 FOR NORFLOXACIN
Ab Biodisk, SE
JWY
Nov 25, 1998K983259SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
Ab Biodisk, SE
JWY
Oct 2, 1998K983027TRIMETHOPRIM/SULPHAMETHOXAZOLE
Ab Biodisk, SE
JWY
Sep 30, 1998K982868ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE
Ab Biodisk, SE
JWY
Sep 3, 1998K981639SYSTEM U3 FOR CIPROFLOXACIN
Ab Biodisk, SE
JWY
Jul 6, 1998K980877ETEST CEFDINIR
Ab Biodisk, SE
JWY
Jun 15, 1998K980335ETEST BENZYLPENICILLIN
Ab Biodisk, SE
JWY
Jun 9, 1998K981137ETEST CEFOTAXIME
Ab Biodisk, SE
JWY
Jun 9, 1998K981136ETEST FOSFOMYCIN
Ab Biodisk, SE
JWY
Jun 9, 1998K981135ETEST BENZYLPENICILLIN
Ab Biodisk, SE
JWY
Jun 5, 1998K981138ETEST CIPROFLOXACIN
Ab Biodisk, SE
JWY
Jun 1, 1998K981139ETEST CEFTRIAXONE
Ab Biodisk, SE
JWY
May 29, 1998K980348ETEST VANCOMYCIN
Ab Biodisk, SE
JWY
May 29, 1998K980342ETEST CHLORAMPHENICAL
Ab Biodisk, SE
JWY
May 28, 1998K981134ETEST TETRACYCLINE
Ab Biodisk, SE
JWY
May 28, 1998K980338ETEST OFLOXACIN
Ab Biodisk, SE
JWY
May 27, 1998K980347ETEST TETRACYCLINE
Ab Biodisk, SE
JWY
May 27, 1998K980345ETEST CEFTRIAXONE
Ab Biodisk, SE
JWY
May 18, 1998K980773ETEST GREPAFLOXACIN
Ab Biodisk, SE
JWY
May 13, 1998K980603ETEST TROVAFLOXACIN
Ab Biodisk, SE
JWY
Jul 14, 1997K971697ETEST FOR LEVOFLOXACIN
Ab Biodisk, SE
JWY
Jun 30, 1997K971694ETEST FOR CEFTAZIDIME
Ab Biodisk, SE
JWY
May 1, 1997K970473ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
Ab Biodisk, SE
JWY
May 1, 1997K970210AMIKACIN
Ab Biodisk, SE
JWY
May 1, 1997K964236(MODIFIED) ETEST PACKAGE INSERT
Ab Biodisk, SE
JWY
Apr 25, 1997K970820ETEST SPARFLOXACIN
Ab Biodisk, SE
JWY
Dec 18, 1996K964203PIPERACILLIN/TAZOBACTAM 4
Ab Biodisk, SE
JWY

Newest 50 of 64.

Latest recalls

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