Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- GIATest, Leukocyte Peroxidase1Product Code
- NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr2Product Code
- K100980INVADER FACTOR V2Cleared 510(K)
- K093129ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II2Cleared 510(K)
- K093974ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING2Cleared 510(K)
- K082118XPERT HEMOSIL FACTOR II & FACTOR V ASSAY2Cleared 510(K)
- K060564INFINITI SYSTEM2Cleared 510(K)
- DEN030005FACTOR V LEIDEN KIT2Cleared 510(K)
- NPRTest, Factor Ii G20210a Mutations, Genomic Dna Pcr2Product Code
- PHJSystem, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations2Product Code
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K093974
- 510(k) Type
- Traditional
- Applicant
- Osmetech Molecular Diagnostics
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/22/2010
- Days to Decision
- 120 days
- Submission Type
- Statement