Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- OYTBlood Establishment Computer Software, User DevelopedUProduct Code
- QHRBlood Grouping ReagentUProduct Code
- QHSAnti-Human GlobulinUProduct Code
- QHTReagent Red Blood CellsUProduct Code
- KSJSystem, Identification, Hepatitis B Antigen3Product Code
- MTHTray, Leukocyte TypingNProduct Code
- MTKKit, Sample Collection, Hiv3Product Code
- MTLMonitor,Test,Hiv-13Product Code
- MTNTest, Syphilis, TreponemalNProduct Code
- MTOSoftware, Management, Microplate AssayNProduct Code
- MTPAntibody To Htlv-1, Elisa3Product Code
- MTQSoftware, Blood Virus ApplicationsNProduct Code
- MTRProgenitor Cell Enumeration2Product Code
- MTSVials, Challenge, EndotoxinNProduct Code
- MVWKit, Western Blot, Hiv-1NProduct Code
- MVXAntibody, Monoclonal Blocking, Hiv-1NProduct Code
- MVYMonoclonal, Hiv-1NProduct Code
- MVZSystem, Test, Home, Hiv-13Product Code
- MWBKit, Test, Saliva, Hiv-1&23Product Code
- MWOReagent, Blood Bank, Quality ControlNProduct Code
- MYKKit, Cord Blood CollectionNProduct Code
- MYPTest, Platelet Antibody2Product Code
- MYQKit, Antibody, ElutionNProduct Code
- MYSDevice, Ahf, Automated CryoprecipitationNProduct Code
- MYWIrradiation, Blood IndicatorsNProduct Code
- MYYSeparator, Semi-Automated, Blood Component1Product Code
- MZHTest, Quantitative, For Hla, Non-DiagnosticNProduct Code
- MZITest, Qualitative, For Hla, Non-DiagnosticUProduct Code
- MZJSystem, Concentration, Hematopoietic Stem Cell3Product Code
- MZKSystem, Separation, Hematopoietic Stem Cell3Product Code
- NDVTest, Ecarin Clotting Time (Ect)FProduct Code
- OTQResearch Use Only/Hematology DevicesNProduct Code
- OVGMagnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml)FProduct Code
- PBAEcarin Clotting TimeFProduct Code
- PCZInvestigational Use Only - ImmunologyNProduct Code
- PDCInvestigational Use Only - HematologyNProduct Code
- PEPMolecular Erythrocyte Typing Test3Product Code
- PJFIlluminator System For Blood Products3Product Code
- PZTPeripheral Blood Processing Device For OsteoarthritisNProduct Code
- PZUBone Marrow Processing Device For Clinical UseNProduct Code
- PZVPeripheral Blood Processing Device For Clinical UseNProduct Code
- QBGAssay, Oral Direct Thrombin InhibitorNProduct Code
- QCZMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, With Applicator3Product Code
- QPWReagents And Transportation Supplies, Sodium Citrate Blood Specimen Collection TubeNProduct Code
- QTYVon Willebrand Factor Assay2Product Code
- QWYMechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator3Product Code
- SACAdamts13 Activity Test System2Product Code
- QZVPediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury3Product Code
- SALDevice, Automated Cell Locating, Bone Marrow3Product Code
- SCKLdt, Non-Molecular Antisera For Rare Rbc Antigens When There Is No Alternative IvdNProduct Code
- SESNon-Factor Replacement Product Test System2Product Code
- Submissions with No Product CodeMiscellaneous
- K870042ASSERA-PLATE PROTEIN S KITCleared 510(K)
- K864611IMMUNO-SURECleared 510(K)
- K852834ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & LCleared 510(K)
- K852643UNI-PLATECleared 510(K)
- K852787TECHNICON H*1 SYSTEMCleared 510(K)
- K852107SICKLE-CHEXCleared 510(K)
- K840801DIA-H 1/2/3 & DIA-HT 1/2/3Cleared 510(K)
- K834021SYSMEX CC-780 EIGHT PARAMETER AUT0Cleared 510(K)
- K840128COUNTER MODEL S880Cleared 510(K)
- K840042SDI PREPAX DILUKIT CACleared 510(K)
- K823283FLUSHING SOLUTIONCleared 510(K)
- K820199FETALSCREENCleared 510(K)
- K791658WRIGHT STAIN PACKCleared 510(K)
- K791092ESTERASE-CHLOROESTERASE, STAINING KITCleared 510(K)
- K780817GLOBIN-TERGECleared 510(K)
- K760484STAIN SET, HISTOCHEMICAL AFBCleared 510(K)
- 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
- 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
FETALSCREEN
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K820199
- 510(k) Type
- Traditional
- Applicant
- ORTHO DIAGNOSTIC SYSTEMS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/12/1982
- Days to Decision
- 106 days