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- 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
- K983310SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN2Cleared 510(K)
- K935805PASCO MIC AND MIC/ID PANELS2Cleared 510(K)
- K895362BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST2Cleared 510(K)
- K880574MODIFIED IMIPENEM SUSCEPTIBILITY POWDER2Cleared 510(K)
- K872081CIPRO (TM) DIAGNOSTIC POWDER2Cleared 510(K)
- K864442NORFLOXACIN SUSCEPTIBILITY POWDER2Cleared 510(K)
- K860031GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK2Cleared 510(K)
- K855207IMIPENEM 10 MCG SENSITIVITY DISCS2Cleared 510(K)
- K855106IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/316452Cleared 510(K)
- K855071IMIPENEM SUSCEPTIBILITY POWDER2Cleared 510(K)
- K830758AZLIN AZLOCILIN SODIUM-DIAG. REAGENT2Cleared 510(K)
- K822866MOXALACTAM2Cleared 510(K)
- K822329ANTITUBERCULOUS DRUGS (SIRE)2Cleared 510(K)
- K820578MEZLIN DIAGNOSTIC REAGENT2Cleared 510(K)
- N50407STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE2PMA Approval
- N50413GEOPEN SUSCEPTIBILITY POWDER2PMA Approval
- N50163STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN)2PMA Approval
- N50042POTASSIUM PENICILLIN G DIAG SYS POWDER2PMA Approval
- N50009TERRAMYCIN DIAGNOSTIC SUSCEPTIBILITY POWDER2PMA Approval
- N50062OLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER2PMA Approval
- N50036STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW2PMA Approval
- N50016BACITRACIN DIAGNOSTIC SUSCEPTIBILITY POWDER2PMA Approval
- N50100VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN2PMA Approval
- N61034LINCOCIN SUSCEPTIBILITY PWD2PMA Approval
- 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
- 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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GEOPEN SUSCEPTIBILITY POWDER
- Page Type
- PMA Approval
- Applicant
- PFIZER, INC.
- Trade Name
- GEOPEN SUSCEPTIBILITY POWDER
- Generic Name
- Susceptibility test powders, antimicrobial
- Decision Date
- 9/10/1970
- Days to Decision
- 0 days
- Decision Code
- APRL
- FDA Decision
- Reclassification after approval