Anesthesiology
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- HematologyReview Panel
- 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
- JIPBlood, Occult, Enzymatic Method, In Urine2Product Code
- JPHTest, Erythrocyte Sedimentation Rate1Product Code
- JPIDevice, Hematocrit Measuring2Product Code
- KHEReagent, Occult Blood2Product Code
- K173212Instant-view-PLUS immunochemical Fecal Occult Blood Test2Cleared 510(K)
- K170548InSure ONE2Cleared 510(K)
- K171484hema-screen SPECIFIC Gold2Cleared 510(K)
- K162333Wondfo One Step Fecal Occult Blood (FOB) Test2Cleared 510(K)
- K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test2Cleared 510(K)
- K143325OC-Light S FIT2Cleared 510(K)
- K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT2Cleared 510(K)
- K113506IND ONE STEP OCCULT BLOOD (FOB) TEST2Cleared 510(K)
- K110309FOB ONE STEP RAPID TEST2Cleared 510(K)
- K102664HEMA SCREEN ER2Cleared 510(K)
Show All 97 Submissions
- 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
- ImmunologyReview Panel
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- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
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- UnknownReview Panel
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K121397
- 510(k) Type
- Traditional
- Applicant
- SEKISUI DIAGNOSTICS, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/28/2012
- Days to Decision
- 233 days
- Submission Type
- Summary