Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043088937

FEI Number

3043088937

Entity Name

SCITEK GLOBAL CO.,LTD

City/State/Country

Jinan Shandong, CN

Establishment Address

Room 5, Building 5, Jinan Biomedical Zone, No. 30766 Jingshi East Road, Jinan, Shandong, Jinan Shandong 250000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Scitek Global Co.,Ltd (Owner Number: 10094524)

Owner / Operator Contact Address

Room 5, Building 5, Jinan Biomedical Zone, No. 30766 Jingshi East Road, Jinan, Shandong, Jinan, CN-SD 250000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

lsothermal Amplification System Molecular Biology Instruments Manifolds Vacuum Filtration Rotary Slice Vacuum Pump Water Circulating Vacuum Pump Diaphragm Vacuum Pump Chemical Resistant Vacuum Pump Oil-free Vacuum Suction Filter Pump Colorimeter Fluorescence Spectrophotometer ABBE Refractometer Turbidity Meters Single Beam Spectrophotometer Gloss Meter Micro-Volume UV/VIS Spectrophotometer UV Visible Spectrophotometer Polarimeters Spectrophotometer Atomic Absorption Spectrophotometer Hazemeter Portable Refractometer Melting Point Apparatus Scanning Spectrophotometer Refractometers Grating Spectrophotometer NIR Spectrophotometer Automatic Refractometer Flame Photometer Semi-auto Coagulation Analyzer Coagulation Analyzer Auto Coagulation Analyzer Blood Bank Refrigerator Mini Laboratory Refrigerator Solar Refrigerator Corpse Refrigerator Combination Freezer Portable Ultra-low Temperature Freezer Single Door Laboratory Refrigerator Ultra Low Temperature Freezer Tuna Freezer Car Refrigerator Double Door Laboratory Refrigerator Upright Freezer Freezer Boxes Portable Refrigerator Sieve Shaker Low-temperature constant temperature bath Medical Temperature Controller Device Refrigerated and Heating Circulator Thermostatic baths and circulators Medical Device Vacuum Controller Low Temperature Circulator Rotary Evaporator System Dynamic Temperature Control System Evaporation System Otoscope Low temperature cooling liquid circulator Dynamic Temperature Control System Rotary Evaporator Cooling Circulator Low Temperature Circulator Refrigerated and Heating Circulator Vacuum Controller Balance Tablet Thickness Tester Fully Automatic Sample Digestion System Disintegration Tester Electronic Balance Semi-micro Analytical Balance Constant Temperature and Humidity Incubator Halogen Moisture Analyzer Snowflake Ice Maker Cooling Biochemical Incubator/BOD Incubator Acid And Alkali Storage Cabinet Graphite Digester Microwave Digestion System Hospital Furniture Dissolution Tester Horizontal Shaking Incubator Constant-Temperature Incubator Electronic Analytical Balance (Internal Calibration) Sample Concentrator Total Organic Carbon Analyzer Ultrasonic Cleaner IVC System Automatic Egg Incubator IVC Cage Bullet Ice Maker Tablet Hardness Tester Electronic Analytical Balance (External Calibration) CO2 Incubator Plant Growth Chamber Automatic decapper Biological Safety Cabinet Isolator Block Heater Benchtop Constant-Temperature Incubator Clarity Tester Liquid Dispenser Constant Temperature Shaking Incubator(Benchtop) Homogenizer Microplate Washer Thermal Cycler Climate Incubator Vertical Laminar Flow Cabinet Dispensing Booth Stackable CO2 Incubator Fume Hood Automatic Glassware Washer Stackable CO2 IncubatorTemperature Shaking Incubator Shaking Incubator Electronic Analytical Balance(Touch panel,Internal Calibration) Horizontal Laminar Flow Cabinet Density Meter Pipette Digital Viscometer Chemical Safety Cabinet Lighting Incubator Liquid Vacuum Aspiration Laminar Flow Cabinet Elisa Microplate Reader Hydrostatic balance Viscosity Bath Medicine Stability Testing Chamber Mould Incubator Tablet Friabilty Tester Density Balance In Situ Hybridization Freezing Point Osmometer Livifitup Endurance Portable Trainer Patient Monitor Transfer Electrophoresis Tank Electrophoresis Cell Automatic Gel Imaging and Analysis System Horizontal Electrophoresis Tank Inner Core of Electrophoresis Tank Electrophoresis Power Supply Sequencing Electrophoresis Tank Vertical Electrophoresis Tank Transilluminator Automatic Chemiluminescence Gel Imaging System Portable pH/ORP Meter Portable PH Meter Pocket pH Tester Online pH Meter Benchtop pH/Ion Meter Bluetooth Pocket pH/Conductivity Meter PH Electrode Benchtop pH Meter Electrochemistry & Titration Electrolyte Analyzer Conductivity Meters Dissolved Oxygen Meters Chlorine Meter Ion Meters COD Analyzer Salinity Meters ORP Meters TDS Meters Multiparameter Meters Benchtop PH Meter Titrator Water Hardness Meters Pocket PH Meter Water Purifier Ultra Water Purifier(Low TOC) Deionized Water Purifier Ultra Water Purifier(Synthesizing) Ultra Water Purifier(Physicochemical) Ultra Water Purifier(Eliminating endotoxin) High Pure Water Purifier Gas Chromatograph Blood Collection Tube PRP Tube Medical Consumables ECG Machine Hematology reagent Diluent Colony Counter Molecular Biology Instrument Real-time Fluorescence Quantitative PCR Detection System Slide Stainer Pathology Lab Solution Hemoglobin Analysis Meter Urine Analyzer Fully Automatic Urinalysis Analyzer Semi-Automatic Urinalysis Analyzer Multi Purpose Centrifuges Crude Oil Centrifuge Benchtop High Speed Refrigerated Centrifuge Microplate Centrifuge Oil Test Centrifuge Low Speed Centrifuge Floor-standing High Speed Refrigerated Centrifuge Benchtop Low Speed High Capacity Refrigerated Centrifuge High Speed Mini Centrifuge Low speed Clinical Centrifuge Benchtop Low Speed Centrifuge Cell Washer/Serofuge Centrifuge Benchtop High Speed Micro Refrigerated Centrifuge Benchtop Low Speed High Capacity Centrifuge High Speed Micro Centrifuge Fat Transplantation Centrifuge Cyto Centrifuge Gel Card Centrifuge PRP Centrifuge Benchtop High Speed Centrifuge Hematocrit Centrifuge Mini Centrifuge Inverted Microscope Teaching microscope Metallurgical Microscope Digital Microscope LCD Digital Microscope Biological Microscope Reading microscope Stereoscopic Microscope Fluorescence Microscope Polarizing Micrscope Multi-view Microscope Fluorometer Microplate Mixer Digital Display Heating Mantle Electronic Heating Mantle Mini Magnetic Stirrer Digital & Magnetic Stirring Heating Mantles Vortex Mixer Microplate Shaker Orbital Shaker Rocking Rotator Single-layer Shaker Multi-row Electronic Control Heating Mantle Overhead Stirrer Hotplate Magnetic Stirrer 3D Shaker Multi-tube Vortexer Stainless Steel Hotplate Three- layer Shaker Roller Mixer Glass Ceramic Hotplate Electronic Magnetic Stirring Heating Mantle Heating Mantle Rocking Shaker Magnetic Stirrer Wrist Shaker Microplate Incubator Shaker Linear Shaker Double-layer Shaker Multi-position Magnetic Stirrer Aluminum Hotplate Multi-row Magnetic Stirring Heating Mantles Blood Collection Monitor Blood Plasma Extractor Liquid Chromatograph Mouth Mirror ESR Analyzer Thermostatic Water Bath Thermostatic Shaking Water Bath Thermostatic Magnetic Stirring Bath Thermostatic Water Tank Transparent Water Bath High Precision Low-Temperature Thermostatic Bath Benchtop Constant-Temperature Drying Oven Drying Oven/Incubator(Dual-use) Big Forced Air Drying Oven Forced Air Drying Oven Constant Temperature Drying Oven Vacuum Oven Infrared Fast Heating Drying Oven Horizontal Drying Oven(Natural Convection) Blood Cell Counter Vein Finder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2026-02-09
JDY	Evacuator, Vapor, Cement Monomer	Orthopedic	Class 1	888.4220	2025-12-18
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2025-12-18
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-12-19
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2025-12-18
IDX	Sieves, Tissue	Pathology	Class 1	864.3010	2025-12-19
JRR	Regulator, Temperature	Clinical Chemistry	Class 1	862.2050	2026-02-09
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2025-12-19
JRK	Evaporator	Clinical Chemistry	Class 1	862.2050	2025-12-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2025-12-19
JJM	Osmometer For Clinical Use	Clinical Chemistry	Class 1	862.2730	2025-12-19
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2025-12-19
IWE	Monitor, Patient Position, Light-Beam	Radiology	Class 1	892.5780	2025-12-19
JJN	Apparatus, Electrophoresis, For Clinical Use	Clinical Chemistry	Class 1	862.2485	2025-12-18
JQY	Ph Meter	Clinical Chemistry	Class 1	862.2050	2025-12-19
JJP	Electrode, Ion Selective (Non-Specified)	Clinical Chemistry	Class 1	862.2050	2025-12-05
DOP	Mass Spectrometer, Clinical Use	Clinical Chemistry	Class 1	862.2860	2025-12-18
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2025-12-18
JKT	Gas Chromatograph, Carbon-Monoxide	Clinical Toxicology	Class 1	862.3220	2025-12-19
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2025-12-19
MLN	Electrode, Electrocardiograph, Multi-Function	Cardiovascular	Class 2	870.2360	2025-12-19
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2025-12-19
KZB	Automated Colony Counter	Microbiology	Class 1	866.2170	2025-12-19
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2025-12-19
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2025-12-19
GGF	Acid Hematin	Hematology	Class 2	864.7500	2025-12-19
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2025-12-19
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2025-12-19
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2025-12-18
JZT	Fluorometer	Immunology	Class 1	866.4520	2025-12-19
JRQ	Shaker/Stirrer	Clinical Chemistry	Class 1	862.2050	2025-12-18
KSQ	Device, Blood Mixing And Blood Weighing	Hematology	Class 1	864.9195	2025-12-18
LDM	Instrumentation, High Pressure Liquid Chromatography	Clinical Chemistry	Class 1	862.2260	2025-12-19
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2025-12-19
GKB	Device, Automated Sedimentation Rate	Hematology	Class 1	864.5800	2025-12-19
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2025-12-18
JRJ	Unit, Drying	Clinical Chemistry	Class 1	862.2050	2025-12-19
GHO	Hemocytometer	Hematology	Class 1	864.6160	2025-12-19
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2025-12-18

Official Correspondent

Nancy Hou

US Agent Details

Nancy Hou Business: SCITEK GLOBAL INC. Email: info@scitekglobal.net Phone: (915) 4126735

Related Public Records

Same Entity

Scitek Global 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
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
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.

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3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3003366417	LRE MEDICAL GMBH	NOERDLINGEN Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043088937. Last updated year: 2026. Please use registration number 3043088937 when referencing this establishment in official correspondence.