Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- OYCPump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor3Product Code
- OZOAutomated Insulin Dosing , Threshold Suspend3Product Code
- OZPAutomated Insulin Dosing Device System, Single Hormonal Control3Product Code
- LHEController, Closed-Loop Blood Glucose3Product Code
- LKVEnzyme Immunoassay, Fetal Fibronectin3Product Code
- LMYMonitor, Skin Resistance/Skin Temperature, For Insulin Reactions3Product Code
- LTCHyaline Membrane Disease Assay3Product Code
- MDSSensor, Glucose, Invasive3Product Code
- MWQSystem, Test, Total Antioxidant Status3Product Code
- NCTInstrument, Glucose, Noninvasive Technology3Product Code
- NQCTest, Breath Analysis, Volatile Organic CompoundsFProduct Code
- NUKFor Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test SystemNProduct Code
- NULFor Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test SystemNProduct Code
- OTVResearch Use Only/Clinical Chemistry DevicesNProduct Code
- OZQAutomated Insulin Dosing Device System, Bihormonal Control3Product Code
- PAQTest, Nr2 AntibodyNProduct Code
- PARTest, Volatile Organic Compounds Breath AnalysisFProduct Code
- PDAInvestigational Use Only - Clinical ChemistryNProduct Code
- PEJSalivary Estriol Test3Product Code
- PHKTest, Cell Mediated Immune Response, Liver And Small Bowel Transplant/TransplantationNProduct Code
- PQFSensor, Glucose, Invasive, Non-Adjunctive3Product Code
- PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated3Product Code
- QCDContinuous Glucose Monitor, Implanted, Adjunctive Use3Product Code
- QHJSensor, Glucose, Implanted, Non-Adjunctive Use3Product Code
- QRVSetmelanotide Eligibility Gene Variant Detection System2Product Code
- QWZPrognostic Test For Assessment Of Chronic Kidney Disease Progression2Product Code
- QXCDiabetes Digital Therapeutic Device2Product Code
- SBAIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate2Product Code
- SCHLdt, Approved By Nys ClepNProduct Code
- SCEIvd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCFLdt, Unmet Need Within An Integrated Healthcare SystemNProduct Code
- SCGModified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final RuleNProduct Code
- SCIIvd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- SCJLdt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
- SFUGlucose Range Monitoring System2Product Code
- SFISensor, Glucose, Invasive, Component Of Automated Insulin Delivery System3Product Code
- Submissions with No Product CodeMiscellaneous
- P960031PERIOGARD PERIODONTAL TISSUE MONITORAPWDPMA Approval
- K863920WAKO(TM) ZN TESTCleared 510(K)
- K872792WATERS M600E MULTI-SOLVENT DELIVERY SYSTEMCleared 510(K)
- K864360LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCECleared 510(K)
- K863065HDL CHOLESTEROL-ECleared 510(K)
- K851575DR. BRUNO LNAGE MINI PHOTOMETERCleared 510(K)
- K852747VISIDEX II REAGENT STRIPSCleared 510(K)
- K850140CORNING MAGIC 1-FREE T3 RADIOIMMUNOASSAYCleared 510(K)
- K844092DIAGNOSTIC MICROSOPCE SLIDESCleared 510(K)
- K842965GASTRIN RADIOIMMUNOASSAY TEST KITCleared 510(K)
- P980022MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEMAPPRPMA Approval
- P980022CONTINUOUS GLUCOSE MONITORING SYSTEMAPPRPMA Approval
- P970032SALEST SYSTEMAPPRPMA Approval
- P960031PERIOGARD PERIODONTAL TISSUE MONITORAPPRPMA Approval
- P960031PERIOGARD PERIODONTAL TISSUE MONITORAPWDPMA Approval
- K842588SIMULTROPIN RADIOIMMUNOASSAY KIT LHCleared 510(K)
- K840096SEBUTAPECleared 510(K)
- K842042IL 1312, PH BLOOD GAS MANAGERCleared 510(K)
- K842222DUPONT ACA LIQUID BILIRUBIN CALIBRATORCleared 510(K)
- K842157TRIGLYCERIDE ASSAY KIT-COLORIMETRICCleared 510(K)
- K841506META-3Cleared 510(K)
- K841441SERA-250Cleared 510(K)
- K833787SOMAS CHLORIDE ASSAY KITCleared 510(K)
- K840105APO A-I RIA KIT-HUMAN PLASMA APOLIP-Cleared 510(K)
- K830957FLOW-PAC TRIGLYCERIDE REAGENTCleared 510(K)
- K830785LEECO DIG-QUANT DIAG. TEST KITCleared 510(K)
- K821852DIAGNOSTICS HDL CHOLESTEROL PRECIPITANTCleared 510(K)
- K821060FLUORO-CEPCleared 510(K)
- K821472ULTRACHEM CREA #64972Cleared 510(K)
- K821452DURAZYME CPKCleared 510(K)
- K820652EXHALED HYDROGEN MONITORCleared 510(K)
- K813215Y-GLUTAMYLTRANSFERASECleared 510(K)
- K812318LIPO-SEP CHOLESTEROL AUDIT SYSTEMCleared 510(K)
- K811442KWIK-LAC BETA-LACTAMASE KITSCleared 510(K)
- K810951REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.Cleared 510(K)
- K810003'NO-BOIL' FOLIC ACID KITCleared 510(K)
- K803077BIOLUMIN. SCREENING FOR BACT. BY ATP A.Cleared 510(K)
- K802422HYCEL TRIGYCERIDE II TESTCleared 510(K)
- K801086P-NITROPHENYL PHOSPHATECleared 510(K)
- K801018IMMULON 1, #11-010-3350 & IMMULON 2 #--Cleared 510(K)
- K800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEOCleared 510(K)
- K800671SMAC REPLACEMENT REAGENTS-WASH SOLUTIONSCleared 510(K)
- K800670SMAC REPLACEMENT REAGENTS, WETTING AGENTCleared 510(K)
- K791172OREIA-TU THYROID UPTAKER RATIO ASSAYCleared 510(K)
- K790803SYRINGE TONOMETERCleared 510(K)
- K781734SODIUM CHLORIDE, 0.85%Cleared 510(K)
- K781436DELTA TEST ASSAY, HDL CHLORESTEROLCleared 510(K)
- K781323LDH PROCEDURECleared 510(K)
- K781309GOT PROCEDURECleared 510(K)
- K780680UNIT, SPECTRA, CORRECTED, DIFFERENTIALCleared 510(K)
- K781165CHOLESTEROL & HDL CHOL. PROCEDURECleared 510(K)
- K780592TRANSFER PIPETCleared 510(K)
- K780372CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS.Cleared 510(K)
- K780074LDH-L REAGENT SETCleared 510(K)
- K771843WETTING AGENTSCleared 510(K)
- K772034GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1Cleared 510(K)
- K772031GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GTCleared 510(K)
- K771700TMA BICARBONATE/GLYCEROL DILUENTCleared 510(K)
- K771844WASH SOLUTIONSCleared 510(K)
- K771073GAS CHROMA. ANALYSIS SYS., SERIES 37111Cleared 510(K)
- K771721BARBITAL BUFFERCleared 510(K)
- K771704DERTRAN-COATED CHARCOAL TABLETSCleared 510(K)
- K771585T3 UPTAKE DIAG. KITCleared 510(K)
- K771473MULTISTAT III Y GT TESTCleared 510(K)
- K771467MULTISTAT III ASPARTATE AMINOTRANSFERASECleared 510(K)
- K771382IMMUNOSTAT T3 UPTAKE TESTCleared 510(K)
- K770974CARDIOZYME CK-MB REAGENTSCleared 510(K)
- K771434MULTI-CAVITY EQUILIBRIUM CELLCleared 510(K)
- K771454MICRO SYRINGE & NEEDLECleared 510(K)
- K771084DYNAZYME II Y-GTCleared 510(K)
- K771154CPK-INT TESTCleared 510(K)
- K770827CHROMATOGRAPHY ANALYSIS SYS, MODEL 8500Cleared 510(K)
- K770972CARDIOZYME CK-TOTAL REAGENTSCleared 510(K)
- K770917GLUTAMATE OXALACETIC TRANSAMINASECleared 510(K)
- K770883ULTRAZYME PLUS GOTCleared 510(K)
- K770825SPECTROPHOTOMETERS,34,35,36,3600Cleared 510(K)
- K770815ULTRAZYME PLUS GTCleared 510(K)
- K770660ANALYZER, CENTRIFUGAL, IL MULTISTAT IIICleared 510(K)
- K770605TUBES, HYDROLYSIS, CALIBRATEDCleared 510(K)
- K770495QUANTI. COLORI. DET. OF SERUM IRONCleared 510(K)
- K770062GDH-GLUCOSE (RATE) REAGENT KITCleared 510(K)
- K760242PROBECOT IICleared 510(K)
- K760006RADIOASSAY, CONCEPT 4Cleared 510(K)
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- 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
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
IMMULON 1, #11-010-3350 & IMMULON 2 #--
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K801018
- 510(k) Type
- Traditional
- Applicant
- DYNATECH LABORATORIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/14/1980
- Days to Decision
- 14 days