510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ab Biodisk

Solna, SE

Ab Biodisk appears in FDA device records in Solna, SE. FDA records list 64 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
64
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 64

FDA records hold 64 510(k) clearances for Ab Biodisk between 1991 and 2008. The busiest year on record is 1998, with 21. The most recent is 2008, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ab Biodisk, by decision year
YearClearances
19911
19955
19969
19976
199821
199910
20004
20011
20022
20043
20051
20081
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K081325ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/MLJWYSubstantially Equivalent
K052366ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIAJWYSubstantially Equivalent
K042392DAPTOMYCINJWYSubstantially Equivalent
K042390ETEST FOR GEMIFLOXACINJWYSubstantially Equivalent
K040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGNGZSubstantially Equivalent
K021445ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAEJWYSubstantially Equivalent
K020748ETEST ERTAPENEMJWYSubstantially Equivalent
K010363ETEST MEROPENEMJWYSubstantially Equivalent
K002139ETEST LINEZOLIDLTXSubstantially Equivalent
K001547ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIPJWYSubstantially Equivalent
K000596ETEST GATIFLOXACINJWYSubstantially Equivalent
K000298ETEST MOXIFLOXACINJWYSubstantially Equivalent
K992993ETEST FOR QUINUPRISTIN/DALFOPRISTINLTXSubstantially Equivalent
K990722ETEST FOR CEFUROXIMEJWYSubstantially Equivalent
K990685TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)JWYSubstantially Equivalent
K990297ETEST MINOCYCLINEJWYSubstantially Equivalent
K984581SYSTEM U3 FOR CEPHALOTHINJWYSubstantially Equivalent
K984491SYSTEM U3 FOR CEFUROXIMEJWYSubstantially Equivalent
K983890SYSTEM U3JWYSubstantially Equivalent
K984144SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACIDJWYSubstantially Equivalent
K984087SYSTEM U3 FOR AMPICILLINJWYSubstantially Equivalent
K983565SYSTEM U3 FOR NITROFURANTOINJWYSubstantially Equivalent
K983571SYSTEM U3 FOR TETRACYCLINEJWYSubstantially Equivalent
K983486SYSTEM U3 FOR NORFLOXACINJWYSubstantially Equivalent
K983259SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLEJWYSubstantially Equivalent
K983027TRIMETHOPRIM/SULPHAMETHOXAZOLEJWYSubstantially Equivalent
K982868ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAEJWYSubstantially Equivalent
K981639SYSTEM U3 FOR CIPROFLOXACINJWYSubstantially Equivalent
K980877ETEST CEFDINIRJWYSubstantially Equivalent
K980335ETEST BENZYLPENICILLINJWYSubstantially Equivalent
K981137ETEST CEFOTAXIMEJWYSubstantially Equivalent
K981136ETEST FOSFOMYCINJWYSubstantially Equivalent
K981135ETEST BENZYLPENICILLINJWYSubstantially Equivalent
K981138ETEST CIPROFLOXACINJWYSubstantially Equivalent
K981139ETEST CEFTRIAXONEJWYSubstantially Equivalent
K980348ETEST VANCOMYCINJWYSubstantially Equivalent
K980342ETEST CHLORAMPHENICALJWYSubstantially Equivalent
K981134ETEST TETRACYCLINEJWYSubstantially Equivalent
K980338ETEST OFLOXACINJWYSubstantially Equivalent
K980347ETEST TETRACYCLINEJWYSubstantially Equivalent
K980345ETEST CEFTRIAXONEJWYSubstantially Equivalent
K980773ETEST GREPAFLOXACINJWYSubstantially Equivalent
K980603ETEST TROVAFLOXACINJWYSubstantially Equivalent
K971697ETEST FOR LEVOFLOXACINJWYSubstantially Equivalent
K971694ETEST FOR CEFTAZIDIMEJWYSubstantially Equivalent
K970473ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAEJWYSubstantially Equivalent
K970210AMIKACINJWYSubstantially Equivalent
K964236(MODIFIED) ETEST PACKAGE INSERTJWYSubstantially Equivalent
K970820ETEST SPARFLOXACINJWYSubstantially Equivalent
K964203PIPERACILLIN/TAZOBACTAM 4JWYSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain