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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- GKGCentrifuge, Hematocrit2Product Code
- GKMHand-Tally, Differential1Product Code
- GJGPipette, Quantitative, Hematology1Product Code
- GJWPipette, Pasteur1Product Code
- GKEOsmotic Fragility Testing1Product Code
- GGGGuaiac Reagent2Product Code
- GGXPipette, Sahli1Product Code
- GGYPipette, Diluting1Product Code
- GHCTube, Sedimentation Rate1Product Code
- GHOHemocytometer1Product Code
- GHYHematocrit, Tube, Rack, Sealer, Holder2Product Code
- GIOTube, Collection, Capillary Blood1Product Code
- GKWAggregometer, Platelet, Thrombokinetogram2Product Code
- GLGPlatelet Counting, Manual1Product Code
- JBXAggregrometer, Platelet2Product Code
- JBYAggregometer, Platelet, Photo-Optical Scanning2Product Code
- JBZStudy, Platelet Adhesive2Product Code
- JCADevice, Bleeding Time2Product Code
- JIOBlood, Occult, Colorimetric, In Urine2Product Code
- K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips2Cleared 510(K)
- K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL2Cleared 510(K)
- K111221MISSION U500 URINE ANALYZER2Cleared 510(K)
- K082811URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS2Cleared 510(K)
- K083724WIENER LAB. URINE STRIP 10 AND 112Cleared 510(K)
- K040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS2Cleared 510(K)
- K023297URS-1B (BLOOD TEST)2Cleared 510(K)
- K921495DIA STRIPS SYSTEM, MODIFIED2Cleared 510(K)
- K913005BACTIDROP(TM) LACTOPHENOL ANILINE BLUE2Cleared 510(K)
- K905396HEMASTIX REAGENT STRIPS2Cleared 510(K)
Show All 11 Submissions
- JIPBlood, Occult, Enzymatic Method, In Urine2Product Code
- JPHTest, Erythrocyte Sedimentation Rate1Product Code
- JPIDevice, Hematocrit Measuring2Product Code
- KHEReagent, Occult Blood2Product Code
- OOXAutomated Occult Blood Analyzer2Product Code
- OSLControl, Fecal Occult Blood2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
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UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K232317
- 510(k) Type
- Traditional
- Applicant
- URIT Medical Electronic Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/26/2024
- Days to Decision
- 267 days
- Submission Type
- Summary