Anesthesiology
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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
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- GMBLight, Wood'S, Fluorescence1Product Code
- GTLPhages, Staphylococcal Typing, All Types1Product Code
- JRZMedia, Culture, Amino Acid Assay1Product Code
- JSACulture Media, Antibiotic Assay1Product Code
- JSBCulture Media, Vitamin Assay1Product Code
- JSCCulture Media, General Nutrient Broth1Product Code
- JSDCulture Media, Selective Broth1Product Code
- JSECulture Media, Multiple Biochemical Test1Product Code
- JSFCulture Media, Single Biochemical Test1Product Code
- JSGCulture Media, Non-Selective And Non-Differential1Product Code
- JSHCulture Media, Non-Selective And Differential1Product Code
- JSICulture Media, Selective And Differential1Product Code
- JSJCulture Media, Selective And Non-Differential1Product Code
- JSKSupplement, Culture Media1Product Code
- JSLCulture Media, Anaerobic Transport1Product Code
- JSMCulture Media, Non-Propagating Transport1Product Code
- JSNCulture Media, Propagating Transport1Product Code
- JSPKit, Anaerobic Identification1Product Code
- JSRKit, Identification, Dermatophyte1Product Code
- JSSKit, Identification, Enterobacteriaceae1Product Code
- JSTKit, Fastidious Organisms1Product Code
- JSWKit, Identification, Glucose Nonfermenter1Product Code
- JSXKit, Identification, Neisseria Gonorrhoeae1Product Code
- JSYKit, Identification, Mycobacteria1Product Code
- JSZKit, Identification, Pseudomonas1Product Code
- JTAMonitor, Microbial Growth1Product Code
- JTBDevice, Media Dispensing/Stacking1Product Code
- JTCDevice, Microtiter Diluting/Dispensing1Product Code
- JTLPlasma, Coagulase, Human, Horse And Rabbit1Product Code
- JTMAnaerobic Box Glove1Product Code
- JTODiscs, Strips And Reagents, Microorganism Differentiation1Product Code
- JTQBath, Incubators/Water, All1Product Code
- JTRKit, Quality Control For Culture Media1Product Code
- JTWSystem, Transport, Aerobic1Product Code
- JTXTransport Systems, Anaerobic1Product Code
- JTYCulture Media, For Isolation Of Pathogenic Neisseria2Product Code
- JWXKit, Screening, Staphylococcus Aureus1Product Code
- JWZKit, Screening, Trichomonas1Product Code
- JXAKit, Screening, Urine1Product Code
- JXBKit, Identification, Yeast1Product Code
- JXCKit, Screening, Yeast1Product Code
- KZBAutomated Colony Counter1Product Code
- KZCManual Colony Counter1Product Code
- KZICulture Media, Enriched1Product Code
- KZJDevice, Gas Generating1Product Code
- KZKReader, Zone, Automated1Product Code
- LGADevice, Oxidase Test For Gonorrhea3Product Code
- LIBDevice, General Purpose, Microbiology, Diagnostic1Product Code
- LIODevice, Specimen Collection1Product Code
- LJFDevice, Antimicrobial Drug Removal1Product Code
- LJGQuality Control Slides1Product Code
- K943228MICROSPORIDIUM CONTROL SET1Cleared 510(K)
- K924893MICROSPORIDIUM CONTROL SLIDE1Cleared 510(K)
- K890718GRAM STAIN CONTROL SLIDE1Cleared 510(K)
- K890670CRYPTOSPORIDIUM CONTROL SLIDE1Cleared 510(K)
- K890616BION DIRECT IDENTIFICATION CONTROL SLIDE1Cleared 510(K)
- K883570HISTO-CHECK FUNGAL CONTROL SLIDES1Cleared 510(K)
- K883571HISTO-CHECK PARASITIC CONTROL SLIDES1Cleared 510(K)
- K883567HISTO-CHECK LEGIONELLA CONTROL SLIDES1Cleared 510(K)
- K883568HISTO-CHECK ACID FAST SLIDES1Cleared 510(K)
- K883569HISTO-CHECK GRAM NEGATIVE SLIDES1Cleared 510(K)
- K883208HISTO-CHECK SLIDES1Cleared 510(K)
- K881106ACID FAST BACILLI HISTOLOGY CONTROL SLIDES1Cleared 510(K)
- K881109SPIROCHETES HISTOLOGY CONTROL SLIDES1Cleared 510(K)
- K881112FUNGI HISTOLOGY CONTROL SLIDES1Cleared 510(K)
- K881110LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES1Cleared 510(K)
- K881108PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES1Cleared 510(K)
- K881111INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL1Cleared 510(K)
- K881107INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES1Cleared 510(K)
- K880962ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES1Cleared 510(K)
- K840515ACID FAST BACILLI STAIN CONTROL1Cleared 510(K)
- K840516METACHROMATIC GRANULE STAIN CONTROL1Cleared 510(K)
- K840517PROTOZOA STAIN CONTROL1Cleared 510(K)
- K830134Q-CHECK REAGENT STANDARDS1Cleared 510(K)
- K823706ATS AFB STAIN CONTROL SLIDE1Cleared 510(K)
- K823704ATS GRAM STAIN CONTROL SLIDE1Cleared 510(K)
- K823705ATS PARASITOLOGY STAIN CONTROL SLIDE1Cleared 510(K)
- K822604ACID FAST QUALITY CONTROL SLIDES1Cleared 510(K)
- LKSDevice, Parasite Concentration1Product Code
- LLHReagents, Clostridium Difficile Toxin1Product Code
- LQLGram Positive Identification Panel1Product Code
- LQMGram Negative Identification Panel1Product Code
- LRHInstrument For Auto Reader Of Overnight Microorganism Identification System1Product Code
- LSCNeisseria Controls1Product Code
- LTSTest Reagents, Neisseria Gonorrhoeae Biochemical1Product Code
- MCBAntigen, C. Difficile1Product Code
- MDBSystem, Blood Culturing1Product Code
- MJKDna Probe, Trichomonas Vaginalis1Product Code
- MJMDna Probe, Gardnerella Vaginalis1Product Code
- MLADna Probe, Yeast1Product Code
- NZSFish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast1Product Code
- OMNC. Difficile Nucleic Acid Amplification Test Assay1Product Code
- OUSMethicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt1Product Code
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System2Product Code
- PPUMicrobial Colony Image Assessment System2Product Code
- PQZGbs Culture Media, Selective And Differential1Product Code
- QBDMicrobial Nucleic Acid Storage And Stabilization Device2Product Code
- QBQSystem, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture1Product Code
- QMCTransport Medium, Notified Per The Vtm Guidance1Product Code
- QQYCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms2Product Code
- 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
ATS GRAM STAIN CONTROL SLIDE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K823704
- 510(k) Type
- Traditional
- Applicant
- ALPHA-TEC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/7/1983
- Days to Decision
- 29 days