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
- K011043OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)1Cleared 510(K)
- K981084URISCREEN1Cleared 510(K)
- K972676URINE SCREENING DEVICE1Cleared 510(K)
- K952246TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT1Cleared 510(K)
- K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)1Cleared 510(K)
- K950246MULTIPLE (IZON URINE COLLECTION KIT)1Cleared 510(K)
- K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)1Cleared 510(K)
- K934759CULTURIA MACCONKEY-MUG1Cleared 510(K)
- K924218BAC-T-SCREEN1Cleared 510(K)
- K921045DIASLIDE URINE CULTURING DEVICE1Cleared 510(K)
- K911846URI-THREE(TM), MODIFICATION1Cleared 510(K)
- K903470QUALTURE1Cleared 510(K)
- K894805RAPIDEC UR1Cleared 510(K)
- K892216GEN-PROBE PACE SYSTEM URINE SCREEN1Cleared 510(K)
- K882211URISCREEN1Cleared 510(K)
- K883385RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST1Cleared 510(K)
- K881439MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM1Cleared 510(K)
- K873086ROUND 11Cleared 510(K)
- K870731LYFO KWIK(TM) RUS KIT1Cleared 510(K)
- K864177N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)1Cleared 510(K)
- K864202UTISCREEN(R) BACTERIAL ATP TEST1Cleared 510(K)
- K862195RAPID BACTERIURIA SCREEN (RBS)1Cleared 510(K)
- K861631SLIDE CULTURE U 'EIKEN'1Cleared 510(K)
- K860905URICHECK1Cleared 510(K)
- K860483FILTRA-CHECK-UTI1Cleared 510(K)
- K851399BAC-T-SCREEN1Cleared 510(K)
- K843833BACTERIURIA DETECT DEVICE, MULTI SAMPLER1Cleared 510(K)
- K843834BACTERIURIA DETECT. DEVICE APTEK II1Cleared 510(K)
- K833834ORTHO BACTERIURIA DETECTION SYS1Cleared 510(K)
- K832975BACTERUERIA SCREENING PROCEDURE1Cleared 510(K)
- K830252DIPCHEX DIP-SLIDE CULTURE SYS1Cleared 510(K)
- K823850BAC-T-SCREEN BACTERIURIA DETECTION DEV1Cleared 510(K)
- K820126RAPID BACTERIURIA SCREENING TEST1Cleared 510(K)
- K810746LUMAC'S BACTERIURIA SCREENING KIT1Cleared 510(K)
- K800626URI-DIP (R)1Cleared 510(K)
- K800215CULTURIA MACCONKEY/CLED #DM871Cleared 510(K)
- K792579CULTURIA MACCONKEY/COLUMBIA CNA1Cleared 510(K)
- K792284CULTURIA EMB/COLUMBIA CNA W/5% SHEEP1Cleared 510(K)
- K781370MS-2 AUTOMATED URINE SCREENING SYSTEM1Cleared 510(K)
- K781536VAC-U-PAC KIDNEY CASSETTE1Cleared 510(K)
- K780803TILL-U-TEST, DIP SLIDE1Cleared 510(K)
- K780021URINE SCREENING KITS1Cleared 510(K)
- K780109TILL-U=TEST1Cleared 510(K)
- K771672MICROCULT-ID1Cleared 510(K)
- 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
- 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
URISCREEN
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K882211
- 510(k) Type
- Traditional
- Applicant
- DIATECH DIAGNOSTICA LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/30/1988
- Days to Decision
- 127 days