Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MiscellaneousMiscellaneous
- OYMProstrate Cancer Genes Nucleic Acid Amplification Test System3Product Code
- KTJSystem, Test, Alpha-Fetoprotein, Ria3Product Code
- LOKKit, Test, Alpha-Fetoprotein For Neural Tube Defects3Product Code
- LTQCalibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum3Product Code
- MANAssay, Interleukin3Product Code
- MJBAntigen, Cancer 5493Product Code
- MTFTotal, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer3Product Code
- MTGTest, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions3Product Code
- MYZKit, Test (Donors), For Bloodborne Pathogen2Product Code
- MZATest, Equipment, Automated Bloodborne PathogenNProduct Code
- MZETest, Donor, Cmv2Product Code
- MZFTest, Hiv Detection3Product Code
- MZLKit, Test, Quality Control For EndotoxinNProduct Code
- NAFAntigen(Complexed),Prostate Specific,(Cpsa)3Product Code
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer3Product Code
- NYQChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer3Product Code
- OAWCancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic MesotheliomaFProduct Code
- OCBRt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection3Product Code
- OTRResearch Use Only/Immunology DevicesNProduct Code
- OWDSomatic Gene Mutation Detection System3Product Code
- OYAP2psa3Product Code
- OYYLeukemia Translocation Panel Multiplex TestNProduct Code
- PILTest For Periprosthetic Joint InfectionNProduct Code
- QLCInterleukin 6NProduct Code
- QRFMulti-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer3Product Code
- QSEAlzheimer’S Disease Pathology Assessment Test2Product Code
- QWQAssays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors3Product Code
- SADJapanese Encephalitis Virus Immunological/Serology TestNProduct Code
- SETImmunoassay Blood Test For Amyloid Pathology Assessment2Product Code
- SFCNeurologic Disease Risk Assessment Molecular Test2Product Code
- Submissions with No Product CodeMiscellaneous
- K865019AFT(R) HEP PERFORMANCE EVALUATION PROGRAMCleared 510(K)
- K842501TSS/FIKCleared 510(K)
- K844105FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODYCleared 510(K)
- K834603TRANSFERRIN, ANTIGEN, ANTIBODY, CONTROLCleared 510(K)
- K831496ALLERGEN IMMUNOSORBENTS IP SPECIFIC ECleared 510(K)
- K830280PHADEZYM B2 MICRO TEST 100Cleared 510(K)
- K821815ADVANCE C-REACTIVE PROTEIN (CRP) ASSAYCleared 510(K)
- K821097SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNACleared 510(K)
- K820005TOTAL HEMOLYTIC COMPLEMENT TEST KITCleared 510(K)
- K812371HEMOLYSINCleared 510(K)
- P940035MATRITECH NMP22(TM) TEST KITAPPRPMA Approval
- K790362I BRADYKININ & ANTI-BRADYKININ ANTISERUMCleared 510(K)
- K781143IMMUNOFLUORESCENCE TEST KITCleared 510(K)
- K772248ALBUMIN NEPHELOMETRIC ASSAYCleared 510(K)
- K771941QUANTROLS IMCleared 510(K)
- K771766T3UCleared 510(K)
- K771239GOAT LAMBDA-LIGHT CHAIN ANTIHUMAN SERUMCleared 510(K)
- K770731EAGENT SYSTEM, CORTISOL, ARIACleared 510(K)
- K770965HUMAN REFERENCE SERUMCleared 510(K)
- K770467IN VITRO DIAGNOSTIC TESTCleared 510(K)
- K760955PHADEBAS T4 RIACleared 510(K)
- K760825FUNGAL IMMUNODIFFUSION KITCleared 510(K)
- K760839VASPAR, SEALANT FOR FERMENTATIONSCleared 510(K)
- K760837POTASSIUM HYDROXIDE W/GLYCEROL MTG FL.Cleared 510(K)
- K760836NEGATIVE CONTROL SERUMCleared 510(K)
- K760607HI CHICKEN ANTISERUMCleared 510(K)
- K760608HI CHICKEN PRESERUMCleared 510(K)
- K760606HA ANTIGENCleared 510(K)
- K760396TEST, MACROGLOBULIN KIT (ALPHA2)Cleared 510(K)
- K760089TEST, IN-VITRO DIAGNOSTICCleared 510(K)
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR 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
- 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
IN VITRO DIAGNOSTIC TEST
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K770467
- 510(k) Type
- Traditional
- Applicant
- HOFFMANN-LA ROCHE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/27/1977
- Days to Decision
- 48 days