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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar2Product Code
- JTNSusceptibility Test Discs, Antimicrobial2Product Code
- JTTSusceptibility Test Powders, Antimicrobial2Product Code
- JTZCulture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth2Product Code
- JWYManual Antimicrobial Susceptibility Test Systems2Product Code
- LIEReagent/Device, Inoculum Calibration2Product Code
- LKACulture Media, Antimicrobial Susceptibility Test2Product Code
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation2Product Code
- LOPSolution, Antimicrobial2Product Code
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems2Product Code
- K191918Thermo Scientific Sensititre ARIS HiQ System2Cleared 510(K)
- K191914Thermo Scientific Sensititre ARIS HiQ System2Cleared 510(K)
- K110583SENSITITRE OPTIREAD2Cleared 510(K)
- K103532AUTOREADER 22Cleared 510(K)
- K111677MICROSCAN(R) MICROSTREP PLUS(R)2Cleared 510(K)
- K111205MICROSCAN (R) MICROSTREP PLUS (R) PANELS2Cleared 510(K)
- K101425MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES2Cleared 510(K)
- K081013MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN2Cleared 510(K)
- K071316MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN2Cleared 510(K)
- K063299MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN2Cleared 510(K)
- K063102MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)2Cleared 510(K)
- K063101MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML2Cleared 510(K)
- K063099MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)2Cleared 510(K)
- K063065MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)2Cleared 510(K)
- K063064MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)2Cleared 510(K)
- K063053MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML)2Cleared 510(K)
- K062375MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML)2Cleared 510(K)
- K062923MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)2Cleared 510(K)
- K062927MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML)2Cleared 510(K)
- K062596MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID2Cleared 510(K)
- K062585MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN2Cleared 510(K)
- K062290MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML)2Cleared 510(K)
- K062293MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML)2Cleared 510(K)
- K062276MICROSCAN MICROSTREP PLUS PANEL2Cleared 510(K)
- K062179MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML)2Cleared 510(K)
- K061872MICROSCAN MICROSTREP PLUS PANEL2Cleared 510(K)
- K053243SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES2Cleared 510(K)
- K050043MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN2Cleared 510(K)
- K050585MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE2Cleared 510(K)
- K043545MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)2Cleared 510(K)
- K041150MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS2Cleared 510(K)
- K033948MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)2Cleared 510(K)
- K981199MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN2Cleared 510(K)
- K941425ALAMAR ANTIBIOTIC SUSCEPTIBILITY2Cleared 510(K)
- K930478READAR2Cleared 510(K)
- K921977SYNERGY SCREEN TEST, MODIFICATION2Cleared 510(K)
- K925951READAR2Cleared 510(K)
- K925859READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS2Cleared 510(K)
- K922482MICROSCAN DRI GRAM POSIT/GRAM NEGA MIC/COMBO PANEL2Cleared 510(K)
- K911419SENSITITRE ARIS MODULE2Cleared 510(K)
- K911400WALKAWAY TM 402Cleared 510(K)
- K900821AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING2Cleared 510(K)
- K896447AUTOSCEPTOR2Cleared 510(K)
- K883907SCEPTORPETTE SYSTEM2Cleared 510(K)
- K865062ALADIN (TM)2Cleared 510(K)
- LTTPanels, Test, Susceptibility, Antimicrobial2Product Code
- LTWSusceptibility Test Cards, Antimicrobial2Product Code
- LTXDiscs, Elution2Product Code
- MJASusceptibility Test Powders, Antimycobacterial2Product Code
- MJDCulture Media, Antimycobacteria, Susceptibility Test2Product Code
- MJECulture Media, Antifungal, Susceptibility Test2Product Code
- MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies2Product Code
- NGZSusceptibility Test Plate, Antifungal2Product Code
- NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus Species2Product Code
- NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen2Product Code
- PMYSystem, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony2Product Code
- POCSystem, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen2Product Code
- PRHPositive Blood Culture Identification And Ast Kit2Product Code
- PTJPhenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates2Product Code
- QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay2Product Code
- QZXPositive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing2Product Code
- SANAutomated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples2Product Code
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K043545
- 510(k) Type
- Traditional
- Applicant
- Dade Behring, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/17/2005
- Days to Decision
- 56 days
- Submission Type
- Summary