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
- K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II1Cleared 510(K)
- K883991KVM HEMOGLOBIN LYSING REAGENT1Cleared 510(K)
- K874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT1Cleared 510(K)
- K873348CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.1Cleared 510(K)
- K863114PIASTRINIT1Cleared 510(K)
- K863503HEMOLYSE1Cleared 510(K)
- K850944NSI LYSING-D REAGENT -4000 ML1Cleared 510(K)
- K850097LASER-LYSE1Cleared 510(K)
- K842938ACETIC ACID 1% V/V1Cleared 510(K)
- K842935ACETIC ACID, 5% V/V1Cleared 510(K)
- K842936ACETIC ACID, 3% V/V1Cleared 510(K)
- K842937ACETIC ACID 2% V/V1Cleared 510(K)
- K842069IDL-LYSING REAGENT1Cleared 510(K)
- K841800LYSING & HEMOGLOBIN REAGENT1Cleared 510(K)
- K840289LYSE-TEC1Cleared 510(K)
- K834527THROMBO PLUS1Cleared 510(K)
- K833444LYSING & HEMOGLOBIN S-REAGENT J & S1Cleared 510(K)
- K832182LYSING REAGENT1Cleared 510(K)
- K830186LYSIS +1Cleared 510(K)
- K822324RED CELL LYSING REAGENT 78N 1915-11Cleared 510(K)
- K822504CDL AUTO-LYSING REAGENT1Cleared 510(K)
- K822500CDL LYSING REAGENT1Cleared 510(K)
- K812002ELUAID1Cleared 510(K)
- K802742SERA-PAK TOTAL PROTEIN REAGENT1Cleared 510(K)
- K790029FLUID, RHEMOX W LYSING1Cleared 510(K)
- K782098REAGENT, LYSING AND HEMOGLOBIN1Cleared 510(K)
- K781121HEMOLYSE1Cleared 510(K)
- K771788CYMET-AUTOMATED1Cleared 510(K)
- K761182ISOTONIC DILUENT AF1Cleared 510(K)
- GGLControl, White-Cell2Product Code
- GGMControl, Hemoglobin2Product Code
- GIFDiluent, Blood Cell1Product Code
- 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
ELUAID
- Page Type
- Cleared 510(K)
- 510(k) Number
- K812002
- 510(k) Type
- Traditional
- Applicant
- ORTHO DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/28/1981
- Days to Decision
- 106 days