Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- 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
- LTTPanels, Test, Susceptibility, Antimicrobial2Product Code
- K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)2Cleared 510(K)
- K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)2Cleared 510(K)
- K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)2Cleared 510(K)
- K202343MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )2Cleared 510(K)
- K201423MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)2Cleared 510(K)
- K193536MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)2Cleared 510(K)
- K193358MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)2Cleared 510(K)
- K183127MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)2Cleared 510(K)
- K172337MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)2Cleared 510(K)
- K172912MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)2Cleared 510(K)
- K172255MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)2Cleared 510(K)
- K162740MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)2Cleared 510(K)
- K150039MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)2Cleared 510(K)
- K131275MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS2Cleared 510(K)
- K123933MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE2Cleared 510(K)
- K111394MICROSCAN MICROSTEP2Cleared 510(K)
- K091949MICROSCAN MICROSTREP PLUS, MODEL B1027-2012Cleared 510(K)
- K091264MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B10172Cleared 510(K)
- K083262MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)2Cleared 510(K)
- K062773MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN2Cleared 510(K)
- K062777MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN2Cleared 510(K)
- K033940MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)2Cleared 510(K)
- K030620PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K024357SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K024353SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES2Cleared 510(K)
- K021184MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN2Cleared 510(K)
- K021111MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME2Cleared 510(K)
- K021078MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN2Cleared 510(K)
- K020939MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE2Cleared 510(K)
- K020627MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN2Cleared 510(K)
- K020626MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN2Cleared 510(K)
- K020160DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN2Cleared 510(K)
- K013368HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE2Cleared 510(K)
- K013195HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES2Cleared 510(K)
- K010418DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K010159DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K011116PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST2Cleared 510(K)
- K010508PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K003619DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K001721PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K993102DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K983306SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN2Cleared 510(K)
- K983309SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN2Cleared 510(K)
- K973317PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K972799DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K962150DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K960366SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES2Cleared 510(K)
- K935704DRIED GRAM-NEGATIVE MIC//COMBO PANELS2Cleared 510(K)
- K945235DRIED GRAM-POSITIVE MIC/COMBO PANELS2Cleared 510(K)
- K941030DRIED GRAM-NEGATIVE CEFPODOXIME2Cleared 510(K)
- N62160MIC PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N50494MIC ANTIBIOTIC TEST PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- N62160MIC PANELS2PMA Approval
- 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
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K172255
- 510(k) Type
- Traditional
- Applicant
- Beckman Coulter, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/1/2017
- Days to Decision
- 128 days
- Submission Type
- Summary