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
- 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
- K023677OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)1Cleared 510(K)
- K920416SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB1Cleared 510(K)
- K912558GULL ELISAWARE1Cleared 510(K)
- K872273CORNING EASY WASH ELISA PLATES1Cleared 510(K)
- K871559CELL LIFTER1Cleared 510(K)
- K864249NORMAL SALINE STERILE1Cleared 510(K)
- K863789CORNING ELISA PLATES1Cleared 510(K)
- K862112MICROSCOPE SLIDES1Cleared 510(K)
- K854602MINI MASH 20001Cleared 510(K)
- K854604AUTO MASH1Cleared 510(K)
- K854602MINI MASH 20001Cleared 510(K)
- K854423IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES1Cleared 510(K)
- K853285MYWASHER 51Cleared 510(K)
- K853745MIC-CONCEPT VIEWBOX1Cleared 510(K)
- K850725QUADRA TITER MICRO PLATES1Cleared 510(K)
- K844476PORTABLE DIAGNOSTIC LABORATORY1Cleared 510(K)
- K844442RAPID DIAGNOSTIC KIT1Cleared 510(K)
- K844473HAND-HELD SLIDE READER1Cleared 510(K)
- K843483PHARMA-PLAST PETRI DISH1Cleared 510(K)
- K842052GIARDIA GUARD1Cleared 510(K)
- K842057MACLEAN-FOGG, DISPOS-INOCULA-LOOPS1Cleared 510(K)
- K841632CODE-A-WELL SERIES 200 PLATE1Cleared 510(K)
- K841937CODE-A-WELL SERIES 300 PLATE1Cleared 510(K)
- K841390CODE-A-WELL1Cleared 510(K)
- K833131HCC-MYCOBACTERIA STAIN KIT1Cleared 510(K)
- K831641READER MICROELISA SYSTEM1Cleared 510(K)
- K832117IMMULON SUBSTRATE REMOVAWELL STRIPS1Cleared 510(K)
- K831643STRIPREADER MICROELISA SYSTEM1Cleared 510(K)
- K831642HEATING BLOCK MICROELISA SYSTEM1Cleared 510(K)
- K831658MICROELISA COMP1Cleared 510(K)
- K831448SPIA SYS FOR SOLID PHASE IMMUNOASSAYS1Cleared 510(K)
- K831450DISPOSABLE STERILE FILTER SYSTEM1Cleared 510(K)
- K823787HANDI-WASH1Cleared 510(K)
- K823833MICRO STIX #011-010-5000 & HOLDER#51001Cleared 510(K)
- K823557REMOVAWELL PLATE LID1Cleared 510(K)
- K822960MICROFLUOR B PLATE & MICRO FLUOR W PLATE1Cleared 510(K)
- K822962MICROFLUOR B REMOVAWELL STRIPS1Cleared 510(K)
- K822292DISPOSABLE DISPENSING-SPREAD PIPETS1Cleared 510(K)
- K820346CALI-PIPETTE1Cleared 510(K)
- K820345CALI-LOOP1Cleared 510(K)
- K820043TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY1Cleared 510(K)
- K813640MINIWASH II1Cleared 510(K)
- K812068PROPOSED CONTROLS FOR DOSIMETRIC RELEASE1Cleared 510(K)
- LIODevice, Specimen Collection1Product Code
- LJFDevice, Antimicrobial Drug Removal1Product Code
- LJGQuality Control Slides1Product Code
- 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
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K854423
- 510(k) Type
- Traditional
- Applicant
- DYNATECH LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/20/1985
- Days to Decision
- 15 days