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
- DEPLambda, Peroxidase, Antigen, Antiserum, Control2Product Code
- DEYIgm, Peroxidase, Antigen, Antiserum, Control2Product Code
- DFDKappa, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGHIgd, Peroxidase, Antigen, Antiserum, Control2Product Code
- DAAIgg, Peroxidase, Antigen, Antiserum, Control2Product Code
- DGOIge, Peroxidase, Antigen, Antiserum, Control2Product Code
- K943194IMMULITE(R) ALLERGY FOOD PANEL FP5E2Cleared 510(K)
- K920087IGE EIA TEST KIT2Cleared 510(K)
- K911511ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED2Cleared 510(K)
- K894039QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION2Cleared 510(K)
- K893125BECKMAN EPSILON(TM) IGE REAGENT KIT2Cleared 510(K)
- K872801ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 52Cleared 510(K)
- K860851ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM2Cleared 510(K)
- K853607ALLERG-E IGE ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K831984POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE2Cleared 510(K)
- K831987EPSILON IGE TEST KIT2Cleared 510(K)
- K831774LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-2Cleared 510(K)
- K830653POLYSTYRENE MICROTITER PLATE IMMUNOSORB2Cleared 510(K)
- K830495POLYSTYRENE MICROTITER PLATE IMMUNOSOR2Cleared 510(K)
- K821094IP SPECIFIC E2Cleared 510(K)
- K800995IMMUNOGLOBULIN E TEST KIT2Cleared 510(K)
- DHFD/Km-1, Antigen, Antiserum, Control1Product Code
- LYECytokeratins2Product Code
- NUASystem, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection2Product Code
- PFRSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection2Product Code
- PFSSystem, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection2Product Code
- PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection2Product Code
- PKBAutosomal Recessive Carrier Screening Gene Mutation Detection System2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- 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
IP SPECIFIC E
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K821094
- 510(k) Type
- Traditional
- Applicant
- DIAGNOSTIC REAGENT TECH.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/7/1982
- Days to Decision
- 18 days