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
- 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
- K243625Xpert MRSA/SA SSTI2Cleared 510(K)
- K243070Xpert® SA Nasal Complete2Cleared 510(K)
- K191742ARIES MRSA Assay2Cleared 510(K)
- K190771Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System2Cleared 510(K)
- K162444Xpert MRSA NxG2Cleared 510(K)
- K142721cobas MRSA/SA Test2Cleared 510(K)
- K133605BD MAX MRSA XT, BD MAX INSTRUMENT2Cleared 510(K)
- K132822BD MAX STAPHSR ASSAY, INSTRUMENT2Cleared 510(K)
- K132468MRSA/SA ELITE MGB, ELITE MGB SOFTWARE2Cleared 510(K)
- K130894XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE2Cleared 510(K)
- K120138BD MAX MRSA ASSAY, BD MAX INSTRUMENT2Cleared 510(K)
- K112937MRSA/SA ELITE MGB2Cleared 510(K)
- K112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)2Cleared 510(K)
- K102740NUCLISENS EASYQ MRSA; NUCLISENS EASYQ ANALYZER; NUCLISENS EASYQ INCUBATOR (110 VOLT); NUCLISENS DIRECTOR V.2.62Cleared 510(K)
- K101879XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-102Cleared 510(K)
- K091409LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 052057272Cleared 510(K)
- K100822XPERT MRSA/SA NASAL ASSAY2Cleared 510(K)
- K093346BD GENEOHM MRSA ACP ASSAY2Cleared 510(K)
- K082140XPERT MRSA/SA BLOOD CULTURE ASSAY2Cleared 510(K)
- K080837XPERT MRSA/SA SSTI ASSAY2Cleared 510(K)
- K071026BD GENEOHM STAPHSR ASSAY2Cleared 510(K)
- K070462XPERT MRSA2Cleared 510(K)
- K042357IDI-MRSA ASSAY2Cleared 510(K)
- K033415IDI-MRSA2Cleared 510(K)
- 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
BD MAX MRSA ASSAY, BD MAX INSTRUMENT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K120138
- 510(k) Type
- Traditional
- Applicant
- BD DIAGNOSTICS (GENEOHM SCIENCES CANADA, INC)
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/5/2012
- Days to Decision
- 170 days
- Submission Type
- Summary