Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- 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
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- GIRReagent, Russel Viper Venom1Product Code
- GJNFluid, Diluting, Red-Cell1Product Code
- GJPControl, Platelet2Product Code
- GJRControl, Red-Cell2Product Code
- GFSStandards And Controls, Hemoglobin, Normal And Abnormal2Product Code
- GGJFluid, Diluting, White-Cell1Product Code
- GGKProducts, Red-Cell Lysing Products1Product Code
- GGLControl, White-Cell2Product Code
- GGMControl, Hemoglobin2Product Code
- GIFDiluent, Blood Cell1Product Code
- K883990KVM ISOTONIC DILUENT1Cleared 510(K)
- K883989KVM ISOTONIC FLUSH SOLUTION1Cleared 510(K)
- K882490HYCEL QUICK-LYSING HEMOGLOBIN REAGENT1Cleared 510(K)
- K882267SYSMEX QUICKLYSER-II (QLS-200A)1Cleared 510(K)
- K881130CELL-DYN ISOTONIC DILUENT1Cleared 510(K)
- K873347CELL-DYN DIFF. SCREEN ISOTONIC DILUENT1Cleared 510(K)
- K851843OSMOCEL 31Cleared 510(K)
- K851320SDI PREPAX DILUKIT M.1Cleared 510(K)
- K851280DASS PACK1Cleared 510(K)
- K850239SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-1Cleared 510(K)
- K850095LASER-DIL1Cleared 510(K)
- K844782NSI ELT-D DILUTING FLUID 4000ML1Cleared 510(K)
- K842929HAYEM DILUTING FLUID1Cleared 510(K)
- K842068IDI ISOTONIC DILUENT1Cleared 510(K)
- K841799CYANOMETHEMOGLOBIN REAGENT1Cleared 510(K)
- K840477UNITIZED HEMATOLOGY SET 65132/931Cleared 510(K)
- K840041SDI PREPAX DILUKIT HW1Cleared 510(K)
- K833972QUICK-COUNT HEMATOLOGY REAGENT KIT1Cleared 510(K)
- K840043SDI PREPAX DILUKIT CT1Cleared 510(K)
- K840038PREPAX DILUKIT PLUS1Cleared 510(K)
- K833443ISOTONIC BLOOD CELL DILUENT J & S1Cleared 510(K)
- K832116ATAC 4700 HEMATOLOGY CELL COUNTER1Cleared 510(K)
- K831617DILUENT1Cleared 510(K)
- K830188OSMOCEL +1Cleared 510(K)
- K822325BLOOD CELL DILUENT 78N 19131Cleared 510(K)
- K822501CDL ISOTONIC DILUENT1Cleared 510(K)
- K821683REAGENT FOR COULTER COUNTER MODEL 5+111Cleared 510(K)
- K812309CRYOSAN NORMAL SALINE1Cleared 510(K)
- K801357MODIFIED BLOOD CELL COUNTING & LYSING1Cleared 510(K)
- K801346NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA1Cleared 510(K)
- K800180VARIOUS REAGENTS FOR BLOOD CELL ANALYZER1Cleared 510(K)
- K790442ISOTONIC DILUENT1Cleared 510(K)
- K790028DILUENT, CELLENT BLOOD1Cleared 510(K)
- K781008ISOTONIC DILUENT1Cleared 510(K)
- K780830ISOTONIC BUFFERED SALINE1Cleared 510(K)
- K771787AZIDE FREE BLOOD DILUTING REAGENT1Cleared 510(K)
- K760129SALINE, ISOTONIC BUFFERED, AZIDE-FREE1Cleared 510(K)
- K760124AUTO CELL DILUENT1Cleared 510(K)
- GLKControl, Hematocrit2Product Code
- GLQMixture, Control, White-Cell And Red-Cell Indices2Product Code
- JCFLymphocyte Separation Medium1Product Code
- JCGFluid, Diluting, Manual Cell1Product Code
- JCNControl, Cell Counter, Normal And Abnormal2Product Code
- JCOBothrops Atrox Reagent2Product Code
- JPKMixture, Hematology Quality Control2Product Code
- KRXCalibrator For Cell Indices2Product Code
- KRYCalibrator For Platelet Counting2Product Code
- KRZCalibrator For Hemoglobin And Hematocrit Measurement2Product Code
- KSACalibrator For Red-Cell And White-Cell Counting2Product Code
- MZGTest, Residual, Wbc In Leukoreduced Blood2Product Code
- NRFMaterial, Quality Control, Semen Analysis2Product Code
- NRSControl Material, Blood Circulating Epithelial Cancer Cell2Product Code
- 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
- MicrobiologyReview Panel
- 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
MODIFIED BLOOD CELL COUNTING & LYSING
- Page Type
- Cleared 510(K)
- 510(k) Number
- K801357
- 510(k) Type
- Traditional
- Applicant
- COULTER ELECTRONICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/14/1980
- Days to Decision
- 66 days