Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027645317

FEI Number

3027645317

Entity Name

INFITEK CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

ROOM 201A, BUILDING 9 (BLOCK B), NO. 2679, HECHUAN ROAD, MINHANG DISTRICT, SHANGHAI,P.C.20, Shanghai 201100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Infitek Co., Ltd. (Owner Number: 10088387)

Owner / Operator Contact Address

ROOM 201A, BUILDING 9 (BLOCK B), NO. 2679, HECHUAN ROAD, MINHANG DISTRICT, SHANGHAI,P.C.20, Shanghai, CN-SH 201100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Water Bath Oscillator Water Bath Oil Bath Transparent Water Bath Thermostatic Magnetic Stirring Bath Laminar Flow Cabinet Gel Imaging System Cellulose Acetate Membrane Electrophoresis Electrophoresis Real-time Monitor Electrophoresis Cell Fast SSR High-Throughput Electrophoresis Tank, Vertical Type Electrophoresis System Lab Ventilation Products Horizontal Electrophoresis Tank 2D gel Electrophoresis system Sequencing Electrophoresis Tank Vertical Electrophoresis Cell Blue Light Integrated Horizontal Electrophoresis Tank Vertical Type Electrophoresis Power Supply Horizontal Type Electrophoresis & Imaging Medical Device Vacuum Controller Evaporation System Low-temperature constant temperature bath Rotary Evaporator System Dynamic Temperature Control System Refrigerated and Heating Circulator Thermostatic baths and circulators Medical Temperature Controller Device Low Temperature Circulator Chest Freezer Blood Bank Refrigerator Refrigerator & Freezer Pharmacy Refrigerator Freezer Combined Refrigerator & Freezer Car Refrigerator Portable Refrigerator Corpse Refrigerator Solar Medicine Refrigerator Cryogenic Freezer Ultra Low Temperature Freezer Pathology Lab Solution Rotary Microtome Microtome Vibrating Microtome Vein Finder Medical Device Rotary Evaporator Evaporation System Rotary Evaporator System Hematology reagent Diluent Pathology Lab Solution Slide Stainer Vacuum Pumps & Filtration Vacuum Pumps Diaphragm Vacuum Pump Water Circulating Vacuum Pump Water Distiller Water Purification Ultra-pure Water Purifier Water Purifier Tablet Friabilty Testers Climate Chamber IVC Cage Lab & Medical Furniture Sample Concentrators Glove Box Egg Incubator Graphite Digester Dissolution Testers BOD Incubator Thermal Cycler Mechanical Analysis Chemical Storage Solution Microplate Washer & Reader Tablet Thickness Testers Intelligent Four-function Tablet Tester Analytical Balances Transparency Tester Pharmaceutical Testing Nucleic Acid Extraction Kits Fume Hoods Hospital Furniture CO2 Incubators Nucleic Acid Extraction Digital Viscometer Emergency Trolley Microplate Washer 802015 Block Heater Labware Cleaning Device PCR Workstation Chemical Safety Cabinet Precision Balances 802003-00 802125 PCR Plate 802025-00 Microwave Digestion/Extraction System Acrylic Glass Simple Glove BoxType A Mould Incubator Air shower room Plant Growth Chamber Moisture Balances Sterilizing Oven Molecular Biology Instruments 802005-00 Pass Box Ice Maker Gelatin Testing Tablet Hardness Testers Freeze Dryer Isolator Veterinary Hematology Analyzer Autoclaves & Sterilizers 802020 802014 802006-00 Disintegration Testers IVC System Aerosol Adsorption Air Purifier Shaking Incubator Platform Scales Clarity Testers Medicine Stability Testing Chamber Illumination chamber Sample Pre-Treatment Products 802124 Acrylic Glass Inert Gas Replacement Glove BoxType B Cooling Incubators Animal Lab Equipment Sieve Shaker Acrylic Glass Vacuum Atmosphere Protection Glove BoxType C Heating Incubator Dispensing Booth Constant Temp. & Humidity Chamber Balances Lab Ventilation Products Nucleic Acid Extraction & Kits Biological Safety Cabinets Acid And Alkali Storage Cabinet Incubators Semi-Micro Balance 802017 802033 Microplate Incubators Liquid Handling Products Liquid Dispenser 802001 In Situ Hybridization Pipettes Stainless Steel Glove Box Gas Cylinder Storage Cabinet 802013 4610-1821 Density Meter Ultrasonic Cleaners Microplate Reader 802024-00 Rat Cage Homogenizers Viscosity Baths 802012 802051 802002-00 Pathology Processing Workstation 802050 PCR Tube PCR-T0.2 802018 802022-00 802123 802049 Medical Device ECG Machine Electrolyte Analyzer In Vitro Diagnostic Medical Devices Gas Chromatograph Chromatograph Orbital Shaker Hotplates & Stirrers Mixer Linear Shaker Roller Mixer Overhead Stirrer Vortex Mixer Combination Stirring Hotplates Heating Mantles Shaker, Microplate Type Magnetic Stirrers Rocking Shaker 3D Shaker Conventional Hotplates Shaker, Mixer, Stirrers Shakers Medical Device Blood Cell Counter PCR-Q16-2 PCR-Q88-2 PCR-Q88-1 PCR Real-time PCR system PCR-Q16-1B PCR-Q96-6 PCR-Q96-6A PCR-Q32-4 PCR-Q16-4F PCR-Q96-5 PCR-Q32-2 PCR-Q32-4F PCR-Q32-2F PCR-Q96-6P PCR-Q88-4 Anaerobic Incubators Molecular Biology Instruments Anaerobic Jar Semi-auto Coagulation Analyzer In Vitro Diagnostic Medical Devices Fully Automatic Coagulation Analyzer Coagulation Analyzer Patient Monitor Medical Consumables PRP Tube Medical Device Blood Collection Tube Freezing Point Osmometer Medical Device Digital Pathology Slide Scanner Pathology Lab Solution Electric suction machine PCR-482 PCR-TC2 PCRTC-32 PCR-96AF PCRTC-G PCR-4832 Thermal Cycler PCR-9632E PCR-9622E PCRTC-S PCR-602S PCR-96D PCRTC-16 PCR-32G PCR-G96XG PCR-96A PCR-96A-384 PCR-96DB PCR-384S PCR-9612E PCR-16 PCR-A96 PCR-96S PCR-4T PCR-96C PCR-96DP PCR-96B Inverted Microscope Metallurgical Microscope Biological Microscope Fluorescence Microscope Digital Microscope Microscopes Teaching Microscope Stereoscopic Microscope Polarizing Microscope PCR-H88-2 Molecular Biology Instruments FD-CT-1600 PCR-H16-2 FD-CT-1600D PCR-H16-1 PCR-H88-1 lsothermal Amplification System Fast Freezing Machine Pathology Lab Solution Microtome Cryostat Microtome Autoclaves & Sterilizers Medical Ultraviolet Ultrasonic Probe Sterilizer Hematology reagent Lyse / Hemolysis Agent Otoscope ENT&Ophthalmology Diagnostic Equipment Benchtop pH Meter pH Meters Electrochemistry & Titration Online PH Meter Portable pH Meter Wall Mounted Shower and Eye Washer Eye Washer Lab & Medical Furniture Combination Shower & Eye Washer Portable Eye Washer Vertical Emergency Eye Washer Removable Eye Washer Emergency Eye Wash Shower Room POCT Testing In Vitro Diagnostic Medical Devices Fluorometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2023-07-12
JJN	Apparatus, Electrophoresis, For Clinical Use	Clinical Chemistry	Class 1	862.2485	2023-07-12
JRR	Regulator, Temperature	Clinical Chemistry	Class 1	862.2050	2023-07-12
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2023-07-12
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2023-07-19
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2023-07-12
JRK	Evaporator	Clinical Chemistry	Class 1	862.2050	2023-07-12
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2024-08-13
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2023-07-12
JDY	Evacuator, Vapor, Cement Monomer	Orthopedic	Class 1	888.4220	2023-07-12
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2023-07-12
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2023-07-12
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2023-07-12
JJR	Electrolyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-07-12
JKT	Gas Chromatograph, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2023-07-12
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2023-07-12
GHO	Hemocytometer	Hematology	Class 1	864.6160	2023-07-12
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2024-03-10
KZJ	Device, Gas Generating	Microbiology	Class 1	866.2580	2023-07-12
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2023-07-12
IWE	Monitor, Patient Position, Light-Beam	Radiology	Class 1	892.5780	2023-07-13
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2023-07-12
JJM	Osmometer For Clinical Use	Clinical Chemistry	Class 1	862.2730	2023-07-12
JQT	Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica	Clinical Chemistry	Class 1	862.2400	2023-07-13
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2024-11-26
OUL	Thermocycler, Generic	Clinical Chemistry	Class 1	862.2310	2024-03-10
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2023-07-12
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2023-07-12
IDP	Microtome, Cryostat	Pathology	Class 1	864.3010	2023-07-12
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-07-12
PDC	Investigational Use Only - Hematology	Unknown	Class N	N/A	2024-08-13
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2023-07-12
JQY	Ph Meter	Clinical Chemistry	Class 1	862.2050	2023-07-12
FLH	Washer Of Body Waste Receptacles	General Hospital	Class 1	880.6800	2023-07-12
JZT	Fluorometer	Immunology	Class 1	866.4520	2023-07-12

Official Correspondent

Carina Xu

US Agent Details

Carrie Yang Business: INFITEK INC. Email: carrieyang@infitek.com.cn Phone: (657) 2320111

Related Public Records

Same Entity

Infitek Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760211	Instrumentation Laboratory CO	ANALYZER, GLUCOSE/UREA/CREATININE	1976-08-26
K021022	Instrumentation Laboratory CO	HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED)	2002-05-14
K113211	Instrumentation Laboratory CO	HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL	2012-01-04
K082859	Instrumentation Laboratory CO	HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED	2008-12-19
K915332	Ciba Corning Diagnostics Corp.	MODEL 795 FLUOROMETER/DENSITOMETER	1992-02-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0514-2014	Instrumentation Laboratory Co.	2	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014	Instrumentation Laboratory Co.	2	HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014	Instrumentation Laboratory Co.	2	HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027645317. Last updated year: 2026. Please use registration number 3027645317 when referencing this establishment in official correspondence.