Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- FLKThermometer, Clinical Mercury2Product Code
- CARMonitor, Spinal-Fluid Pressure, Electrically Powered2Product Code
- FLLThermometer, Electronic, Clinical2Product Code
- FLNMonitor, Electric For Gravity Flow Infusion Systems2Product Code
- FMJManometer, Spinal-Fluid2Product Code
- FQAScale, Surgical Sponge1Product Code
- FQZThermometer, Clinical Color Change1Product Code
- FRCIndicator, Biological Sterilization Process2Product Code
- FRIScale, Stand-On, Patient1Product Code
- FRWScale, Patient1Product Code
- JOJIndicator, Physical/Chemical Sterilization Process2Product Code
- K250172Green Card Bowie-Dick Test (BD115)2Cleared 510(K)
- K242860Type 5 Integrating Indicator for Steam (CSPN-15)2Cleared 510(K)
- K241036Autoclave Indicator Tape; EO Indicator Tape2Cleared 510(K)
- K243475Chemical Indicator for enspire CLCSPS (LCC015)2Cleared 510(K)
- K242795Getinge Assured MI Steam Migrating Integrator2Cleared 510(K)
- K241836Kem Medical Lead-free Chemical Indicators for Steam Sterilization2Cleared 510(K)
- K242189CELERITY HP Indicator Tape (PCC077)2Cleared 510(K)
- K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)2Cleared 510(K)
- K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)2Cleared 510(K)
- K240910EO Chex Indicator Tape2Cleared 510(K)
- K241344MetriCide™ OPA Plus Solution Test Strip2Cleared 510(K)
- DEN2300683M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 11902Cleared 510(K)
- K240032Celerity Chemical Indicator for enspire 3000 CLCSPS2Cleared 510(K)
- K240760CELERITY HP Indicator Tape2Cleared 510(K)
- K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems2Cleared 510(K)
- K233187Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)2Cleared 510(K)
- K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape2Cleared 510(K)
- K230558Revital-Ox PAA High Level Disinfectant Chemical Indicator2Cleared 510(K)
- K222137OK Plus Indicator2Cleared 510(K)
- K220778Chemical Indicator for Steam2Cleared 510(K)
- K2225083M™ Comply™ Hydrogen Peroxide Chemical Indicator 12482Cleared 510(K)
- K2221523M™ Attest™ Hydrogen Peroxide Indicator Tape 12282Cleared 510(K)
- K2209423M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)2Cleared 510(K)
- K2205643M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 13552Cleared 510(K)
- K213412VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM2Cleared 510(K)
- K212592Gas-Chex Indicator2Cleared 510(K)
- K2120813M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 12282Cleared 510(K)
- K200096Crosstex VH2O2 Chemical Indicators2Cleared 510(K)
- K210866Steri-Dot Process Indicator2Cleared 510(K)
- K210553Steam-Dot Process Indicator2Cleared 510(K)
- K2034583M Comply Hydrogen Peroxide Chemical Indicator 12482Cleared 510(K)
- K2032853M Comply Hydrogen Peroxide Indicator Tape 12282Cleared 510(K)
- K202565WAVICIDE-OPA MEC Indicator2Cleared 510(K)
- K200334AN1036 Dosimeter2Cleared 510(K)
- K200272Terragene Chemdye2Cleared 510(K)
- K200252Getinge Assured MI Steam Migrating Integrator2Cleared 510(K)
- K192445QwikCheck Chemical Indicators2Cleared 510(K)
- K1932543M Attest Steam Chemical Integrator2Cleared 510(K)
- K1912363M™ Attest™ Steam Chemical Integrators2Cleared 510(K)
- K1929373M Comply Hydrogen Peroxide Chemical Indicator2Cleared 510(K)
- K1926733M™ Comply™ Hydrogen Peroxide Indicator Tape 12282Cleared 510(K)
- K191999Sterilucent VH2O2 Chemical Indicators2Cleared 510(K)
- K192020Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label2Cleared 510(K)
- K191741Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape2Cleared 510(K)
- K181788Lead-free Chemical Indicators for Steam Sterilization2Cleared 510(K)
- K1832113M Comply Hydrogen Peroxide Chemical Indicator2Cleared 510(K)
- K1832093M Comply Hydrogen Peroxide Indicator Tape2Cleared 510(K)
- K183295Celerity HP Chemical Indicator (CI)2Cleared 510(K)
- K183293VERIFY VH202 Indicator Tape2Cleared 510(K)
- K182724CelerityTM 10 STEAM Chemical Indicator2Cleared 510(K)
- K173428VERIFY Chemical Indicator for S40 Sterilant2Cleared 510(K)
- K171823U&U Indicator tape and strip2Cleared 510(K)
- K172753VERIFY VH2O2 Indicator Tape2Cleared 510(K)
- K172746VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label2Cleared 510(K)
- K172472Micro-MEC 1.8% Glutaraldehyde Monitor Strip2Cleared 510(K)
- K170439AN87 Dosimeter2Cleared 510(K)
- K170426AN85/AN86 EO Indicators2Cleared 510(K)
- K1703213M Comply Hydrogen Peroxide Chemical Indicator 12482Cleared 510(K)
- K1705633M Comply Hydrogen Peroxide Indicator Tape2Cleared 510(K)
- K162758VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack2Cleared 510(K)
- K162631VERIFY STEAM Integrating Indicator - Short2Cleared 510(K)
- K161024Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape2Cleared 510(K)
- K160485VERIFY VH2O2 Indicator Tape2Cleared 510(K)
- K152630VERIFY STEAM Integrating Indicator2Cleared 510(K)
- K152394Rapicide PA High-Level Disinfectant Test Strips2Cleared 510(K)
- K150645AN1087 Dosimeter2Cleared 510(K)
- K150644AN85/AN86 EO Indicators2Cleared 510(K)
- K1506943M Comply Hydrogen Peroxide Indicator Tape 12282Cleared 510(K)
- K1506223M Comply Hydrogen Peroxide Chemical Indicator 12482Cleared 510(K)
- K1504773M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization2Cleared 510(K)
- K143520SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)2Cleared 510(K)
- K143629U&U Bowie-Dick Test Pack2Cleared 510(K)
- K143333Revital-Ox RESERT Solution Test Strip2Cleared 510(K)
- K141698STERIZONE CHEMICAL INDICATOR2Cleared 510(K)
- K140566SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE2Cleared 510(K)
- K140940PROCESS INDICATOR TAPE FOR STEAM STERILIZATION2Cleared 510(K)
- K140515VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL2Cleared 510(K)
- K132291NAMSA CHEMICAL PROCESS2Cleared 510(K)
- K133204AIRVIEW MINI OWIE DICK TEST PACK2Cleared 510(K)
- K132372STERITEC GREEN CARD PACK BOWIE-DICK TEST2Cleared 510(K)
- K130135DANA REUSABLE BI TEST PACK2Cleared 510(K)
- K130160VERIFY PROCESS INDICATOR FOR RELIANCE EPS2Cleared 510(K)
- K130211AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS2Cleared 510(K)
- K122945STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 1262Cleared 510(K)
- K120592DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS2Cleared 510(K)
- K122555STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE2Cleared 510(K)
- K120652RAPICIDE OPA-28 TEST STRIP2Cleared 510(K)
- K111519STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 142022Cleared 510(K)
- K111518STERRAD CHEMIAL INDICATOR STRIP MODEL 141002Cleared 510(K)
- K120435BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR2Cleared 510(K)
- K111453STEAM DOT BLU PROCESS INDICATOR2Cleared 510(K)
- K112256STERIS STEAM PI2Cleared 510(K)
- K103331VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES2Cleared 510(K)
- K102894CLASSIX CHEMICAL STERILIZATION INDICATOR2Cleared 510(K)
- K110369INDISTRIP GREEN2Cleared 510(K)
- K110253REUSABLE TEST PACK FOR DANA EMULATING INDICATORS2Cleared 510(K)
- K110152SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS2Cleared 510(K)
- K103219STERRAD SEALSURE CHEMICAL INDICATOR TAPE2Cleared 510(K)
- K103218STERRAD CHEMICAL INDICATOR STRIP2Cleared 510(K)
- K103053VERIFY 270FP CHALLENGE PACK2Cleared 510(K)
- K103126TROPHON CHEMICAL INDICATOR2Cleared 510(K)
- K103000SMART READ BIOLOGICAL TEST PACK2Cleared 510(K)
- K102296VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2)2Cleared 510(K)
- K102363SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-10042Cleared 510(K)
- K100891DANA EMULATING INDICATOR2Cleared 510(K)
- K102761DANA REUSABLE TEST PACK FOR STEAM STERILIZATION2Cleared 510(K)
- K102217SYSTEM 1E CHEMICAL INDICATOR2Cleared 510(K)
- K1015283M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM2Cleared 510(K)
- K101249STERIGAGE MODEL 1243RA, 1243RB, 1243RE2Cleared 510(K)
- K101580NEV'S INK AUTOCLAVE TAPES2Cleared 510(K)
- K092346SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 51712Cleared 510(K)
- K0931993M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK2Cleared 510(K)
- K091174VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL2Cleared 510(K)
- K090650SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS2Cleared 510(K)
- K083643VERIFY 275F GRAVITY INDICATORS2Cleared 510(K)
- K082620ONCE-A-DAY VERTOS TEST PACK2Cleared 510(K)
- K083295SERIM DISINTEK GTA 2.1%, MODEL: 51642Cleared 510(K)
- K083650EMU-GRAPH 4 EMULATOR, MODEL CI 1442Cleared 510(K)
- K082352SERIM DISINTEK OPA TEST STRIP2Cleared 510(K)
- K081600STERIS RESERT XL TEST STRIP2Cleared 510(K)
- K080136INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 1052Cleared 510(K)
- K081370SERIM DISINTEK OPA TEST STRIP2Cleared 510(K)
- K081427BROWNE OPA TEST STRIP2Cleared 510(K)
- K080750BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR2Cleared 510(K)
- K080307PROCHEM INDICATOR TAPE2Cleared 510(K)
- K072408EMU-GRAPH EMULATOR, MODEL CI 1312Cleared 510(K)
- K073683VERIFY CHALLENGE PACKS - VERSION 22Cleared 510(K)
- K072510VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 22Cleared 510(K)
- K071895VERIFY 275 DEGREE F. 3-10 INDICATOR; 10 INDICATOR; 3 INDICATOR2Cleared 510(K)
- K070895VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACK2Cleared 510(K)
- K070419OPACIDEN OPA REAGENT STRIPS2Cleared 510(K)
- K070461VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 42Cleared 510(K)
- K062651PROCHEM EXT CHEMICAL INTEGRATOR2Cleared 510(K)
- K063285RELIANCE CI PROCESS INDICATOR2Cleared 510(K)
- K063799STEAMPLUS STEAM INTEGRATOR2Cleared 510(K)
- K061738ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD2Cleared 510(K)
- K053479VERIFY DRY HEAT LABEL2Cleared 510(K)
- K060066VERIFY 3-10 MIN FLASH INTEGRATOR2Cleared 510(K)
- K060103ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS2Cleared 510(K)
- K051101VERIFY FLASH INTEGRATOR2Cleared 510(K)
- K052388SERIM PERACETIC ACID CHEMICAL INDICATOR2Cleared 510(K)
- K052516STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 1372Cleared 510(K)
- K043482THE RELIANCE PI PROCESS INDICATOR, MODEL D51162Cleared 510(K)
- K040901STERITEC EMU-GRAPH, MODEL NO. CI 131/US2Cleared 510(K)
- K031152PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)2Cleared 510(K)
- K041017SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK2Cleared 510(K)
- K040742MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE2Cleared 510(K)
- K032801MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR2Cleared 510(K)
- K021161TSO3 OZONE CHEMICAL INDICATOR2Cleared 510(K)
- K024293BOWIE-DICK MINI PAK, MODEL BD 1152Cleared 510(K)
- K031647BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR2Cleared 510(K)
- K030680SPSMEDICAL GAS PLASMA CHEMICAL INDICATOR2Cleared 510(K)
- K022441STERRAD SEALSURE CHEMICAL INDICATOR TAPE2Cleared 510(K)
- K020409STEAMPLUS STERILIZATION TEST2Cleared 510(K)
- K002741BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK2Cleared 510(K)
- K020612SULTAN SPOROX TEST VIAL, MODEL 751952Cleared 510(K)
- K012195STEAM STERILIZATION INTERGRATOR2Cleared 510(K)
- K0205893M COMPLY 1228 GAS PLASMA INDICATOR TAPE2Cleared 510(K)
- K012732INTEGRAPH FLASH, MODEL CI 1102Cleared 510(K)
- K0132283M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR2Cleared 510(K)
- K012335BROWNE METREX 1.8% GLUTARALDEHYDE INDICATOR FOR METRICIDE 28 AND METRICIDE PLUS 30 SOLUTIONS2Cleared 510(K)
- K010534CROSS-CHECKS DUAL, MODEL CI 1252Cleared 510(K)
- K003533CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L2Cleared 510(K)
- K003002STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI1232Cleared 510(K)
- K002861EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 1242Cleared 510(K)
- K0003553M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR2Cleared 510(K)
- K001649STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI12342Cleared 510(K)
- K001444STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 1032Cleared 510(K)
- K000502STEAM/EO RECORD CARD, MODEL CI 1212Cleared 510(K)
- K992767BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR2Cleared 510(K)
- K992341CIDEX OPA SOLUTION TEST STRIP2Cleared 510(K)
- K991709BROWNE CIDEX OPA INDICATOR2Cleared 510(K)
- K991276PASS/FAIL CHALLENGE PACK2Cleared 510(K)
- K991418BROWNE MVI ETHYLENE OXIDE INDICATOR2Cleared 510(K)
- K990246STERI-PAK LF BOWIE-DICK TEST PACK2Cleared 510(K)
- K983451CHALLENGE TEST PACK2Cleared 510(K)
- K982151STERITITE PROCESS INDICATOR ACCESSORIES2Cleared 510(K)
- K984616BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION2Cleared 510(K)
- K984613BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTION2Cleared 510(K)
- K981054BROWNE GA INDICATOR FOR CIDEX PRODUCTS2Cleared 510(K)
- K982188STERI-PAK BOWIE DICK TEST PACK2Cleared 510(K)
- K973585PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR2Cleared 510(K)
- K982547STERITEC CROSS-CHECKS EO GAS STERILIZATION INTEGRATOR2Cleared 510(K)
- K974415KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP2Cleared 510(K)
- K971971BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK2Cleared 510(K)
- K965212STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM2Cleared 510(K)
- K972300CROSS-CHECKS P2Cleared 510(K)
- K971369BROWNE MVI STEAM INDICATOR2Cleared 510(K)
- K971888GLUTATECT2Cleared 510(K)
- K972035SPOROX TEST STRIPS2Cleared 510(K)
- K970918BROWNE STEAM INDICATOR2Cleared 510(K)
- K960441STERITEC INTEGRAPH MODEL CI-1012Cleared 510(K)
- K953122STERITEC DRY HEAT INDICATOR LABEL2Cleared 510(K)
- K961156ONCE-A-DAY BOWIE AND DICK TEST PACK.2Cleared 510(K)
- K952244CROSS-CHECKS EO GAS STERILIZATION MONITOR2Cleared 510(K)
- K960089PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR2Cleared 510(K)
- K955426STERITEC CROSS-CHECKS2Cleared 510(K)
- K952995ATI ETHYLENE OXIDE STERILIZATION INDICATOR2Cleared 510(K)
- K952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION2Cleared 510(K)
- K951063ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION2Cleared 510(K)
- K934066NEPHRETECT2Cleared 510(K)
- K934874STERIGAGE EO 100%2Cleared 510(K)
- K945190STERRAD CHEMICAL INDICATOR TAPE2Cleared 510(K)
- K932057BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK2Cleared 510(K)
- K922481BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE2Cleared 510(K)
- K9321293M AUTOCLAVE TAPES2Cleared 510(K)
- K931935ENDPOINT 500 PERACETIC ACID TEST INDICATORS2Cleared 510(K)
- K924681GLUTARALDEHYDE MONITORS2Cleared 510(K)
- K921910STERRAD CHEMICAL INDICATOR2Cleared 510(K)
- K922485CHEMDI-VHP CHEMICAL INDICATOR2Cleared 510(K)
- K910320SERIM PERACETIC ACID REAGENT STRIPS2Cleared 510(K)
- K902958TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE2Cleared 510(K)
- K895910STEAMLINE2Cleared 510(K)
- K897045BOWIE-DICK TEST CARD CATALOG NUMBER 0080182Cleared 510(K)
- K895422TOWER SELF SEAL STERILIZATION POUCH2Cleared 510(K)
- K890764LABEL, STERILIZATION INDICATOR; RADIATION2Cleared 510(K)
- K890755SEALING TAPE, STERILIZATION INDICATOR; STEAM2Cleared 510(K)
- K890757C-VAPOR STERILIZATION INDICATOR, CHEMICAL VAPOR2Cleared 510(K)
- K890758DRY HEAT STERILIZATION INDICATOR TAPE2Cleared 510(K)
- K890759STRIP, STERILIZATION INDICATOR; STEAM2Cleared 510(K)
- K890760STRIP, STERILIZATION INDICATOR, E.O. GAS2Cleared 510(K)
- K890761STRIP, STERILIZATION INDICATOR; DRY HEAT2Cleared 510(K)
- K890763LABEL, STERILIZATION INDICATOR; DUAL STEAM/E.O.GAS2Cleared 510(K)
- K890765STRIP, STERILIZATION INDICATOR; STEAM OR E.O. GAS2Cleared 510(K)
- K882756LANTOR CUBE STERILIZER TEST PACK2Cleared 510(K)
- K880548SAFE-STRIPS2Cleared 510(K)
- K875193INDISTRIP (STERILIZATION PROCESS INDICATOR)2Cleared 510(K)
- K851804BIO-CHALLENGE TEST PAK2Cleared 510(K)
- K851407SURGICAL TOWELS2Cleared 510(K)
- K844512DART DAILY AIR REMOVAL TEST2Cleared 510(K)
- K843182MASTER-CHEK BOWIE-DICK TYPE TEST2Cleared 510(K)
- K841168STERILIZATION PROCESS INDICATOR2Cleared 510(K)
- K834353OK FLASH STERILIZATION INDICATOR2Cleared 510(K)
- K833074CASTLE TEC-TEST S.M.A.R.T. PACK2Cleared 510(K)
- K833264ADLER STEAM INDICATOR-GAS INDICATOR2Cleared 510(K)
- K831722AC-22 AUTOCLAVE TAPE2Cleared 510(K)
- K823208MYSTIK AUTOCLAVE TAPE2Cleared 510(K)
- K823074CHEMDI STEAM & GAS STERILIZATION INDICA2Cleared 510(K)
- K823036AUTOCLAVE TESTING ADHESIVE TAPE2Cleared 510(K)
- K821997MEDI + BIO SAFE STEAM STERILIZ. INDICAT2Cleared 510(K)
- K821648GAS CHEX PLASTIC BAG2Cleared 510(K)
- K820147STERI-SHURE2Cleared 510(K)
- K813202THERMALOG S STEAM STERILIZATION INTEGRA2Cleared 510(K)
- K813014PROTECT-O-SEAL2Cleared 510(K)
- K812856CHEMICAL INDICATORS2Cleared 510(K)
- K811936CHEMICAL AUTOCLAVE INDICATOR TAPE2Cleared 510(K)
- K810614CASTLE STEAM STERILIZATION INDICATOR2Cleared 510(K)
- K811408STERILIZATION INDICATOR/SEAL PROTECTOR2Cleared 510(K)
- K802634STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.2Cleared 510(K)
- K802229CHEMICAL INDICATOR - KEM MED & BIO SURE2Cleared 510(K)
- K801428CHEMDI2Cleared 510(K)
- K8010573M STEAM STERILIZATION INDICATOR2Cleared 510(K)
- K801109PROOF (BIOLOGICAL/CHEMICAL INDICATOR)2Cleared 510(K)
- K800873TIME STEAM AUTOCLAVE TAPE2Cleared 510(K)
- K792624STERILIZATION PROCESS/ MAYO PAD2Cleared 510(K)
- K772358ETHYLENE OXIDE STERILI. INDICATOR2Cleared 510(K)
- K772135BIOLOGICAL/CHEMICAL INDICATOR2Cleared 510(K)
- K771146STEOILITY TESTING VESSEL2Cleared 510(K)
- K770078CASTLE TEC-TEST STEAM STERI. INTEGRATOR2Cleared 510(K)
- K761011CASTLE TEC-TEST AERATION MONITOR2Cleared 510(K)
- KMIMonitor, Bed Patient1Product Code
- KPDStrip, Temperature, Forehead, Liquid Crystal2Product Code
- LHBTimer, Apgar1Product Code
- LRTIndicator, Sterilization2Product Code
- MRBIndicator, Biological, Liquid Chemical Sterilization Process2Product Code
- MRLScale, Sponge, Surgical, Electrically-Powered1Product Code
- MTCIndicator, Chemical, Enzymatic, Sterilization Process2Product Code
- OCIIndicator, Physical/Chemical, Storage Temperature2Product Code
- OZKThermometer, Exhaled Breath2Product Code
- PJOFall Prevention Alarm/Sensor Combination Attached Or Unattached1Product Code
- PJPFall Prevention Alarm/Sensor Attached Only1Product Code
- PWWFever Monitoring Kit2Product Code
- PXHThermometer Kit2Product Code
- QKMA Chemical Vapor Sterilization Multivariable Chemical Indicator2Product Code
- SBOBed-Patient Activity Monitoring System1Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
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- 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
Terragene Chemdye
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K200272
- 510(k) Type
- Traditional
- Applicant
- Terragene SA
- Country
- Argentina
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/30/2020
- Days to Decision
- 147 days
- Submission Type
- Statement