FDA Registration
Active
🇨🇳 China
LABPEAK CO.,LTD
Reg #: 3043138885
·
FEI: 3043138885
·
Expires 2026
Products
43
Proprietary Names
292
Establishment Types
2
Classifications
43
Registration Details
- Registration Name
- LABPEAK CO.,LTD
- Registration Number
- 3043138885
- FEI Number
- 3043138885
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 4, Building 5, Jinan Biomedical Zone, No. 30766 Jingshi East Road, Jinan, Shandong, China.
- City
- Jinan Shandong
- Country
- CN
Owner / Operator
- Firm Name
- Labpeak Co.,Ltd
- Operator Number
- 10094757
- Address
- Room 4, Building 5, Jinan Biomedical Zone, No. 30766 Jingshi East Road, Jinan, Shandong, China.
- City
- Jinan
- State
- Shandong
- Postal Code
- 250000
- Country
- CN
- Correspondent
- Nancy Hou
US Agent
- Business Name
- SCITEK GLOBAL INC.
- Contact Name
- Nancy Hou
- Address
- 9999 Bellaire Blvd Ste 505 Houston Texas 77036 United States
- City
- Houston
- State
- TX
- ZIP
- 77036
- Country
- US
- [email protected]
- Phone
- 915 4126735
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Device, Vein Location, Liquid Crystal | KZA | Class 1 | General Hospital | No | 2025-12-21 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2026-02-09 |
| Automated Colony Counter | KZB | Class 1 | Microbiology | No | 2025-12-21 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2025-12-21 |
| Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | JJC | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2025-12-21 |
| Diluent, Blood Cell | GIF | Class 1 | Hematology | No | 2025-12-21 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2025-12-21 |
| Electrode, Ion Selective (Non-Specified) | JJP | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Fluorometer | JZT | Class 1 | Immunology | No | 2025-12-21 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2025-12-21 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2025-12-21 |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | JRS | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Monitor, Patient Position, Light-Beam | IWE | Class 1 | Radiology | No | 2025-12-21 |
| Ph Meter | JQY | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Acid Hematin | GGF | Class 2 | Hematology | No | 2025-12-21 |
| Instrumentation, High Pressure Liquid Chromatography | LDM | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Device, Automated Sedimentation Rate | GKB | Class 1 | Hematology | No | 2025-12-21 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Mass Spectrometer, Clinical Use | DOP | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Sieves, Tissue | IDX | Class 1 | Pathology | No | 2025-12-21 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2025-12-21 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2025-12-21 |
| Device, Gas Generating | KZJ | Class 1 | Microbiology | No | 2025-12-21 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2025-12-21 |
| Apparatus, Electrophoresis, For Clinical Use | JJN | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Light, Microscope | IBJ | Class 1 | Pathology | No | 2025-12-21 |
| Hemocytometer | GHO | Class 1 | Hematology | No | 2025-12-21 |
| Gas Chromatograph, Carbon-Monoxide | JKT | Class 1 | Clinical Toxicology | No | 2025-12-21 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2025-12-21 |
| Device, Blood Mixing And Blood Weighing | KSQ | Class 1 | Hematology | No | 2025-12-21 |
| Refrigerator, Freezer, Blood Storage | KSE | Class 2 | Hematology | No | 2025-12-21 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Regulator, Temperature | JRR | Class 1 | Clinical Chemistry | No | 2026-02-09 |
| Osmometer For Clinical Use | JJM | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2025-12-21 |
| Washer Of Body Waste Receptacles | FLH | Class 1 | General Hospital | No | 2025-12-21 |
| Evaporator | JRK | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Unit, Drying | JRJ | Class 1 | Clinical Chemistry | No | 2025-12-21 |
| Evacuator, Vapor, Cement Monomer | JDY | Class 1 | Orthopedic | No | 2025-12-21 |
| Shaker/Stirrer | JRQ | Class 1 | Clinical Chemistry | No | 2025-12-21 |
Proprietary Names
Automatic Refractometer
Refractometers
Fluorescence Spectrophotometer
Visible Spectrophotometer
Melting Point Apparatus
Single Beam Spectrophotometer
Spectrophotometer
UV Visible Spectrophotometer
Gloss Meter
Atomic Absorption Spectrophotometer
Micro-Volume UV/VIS Spectrophotometer
ABBE Refractometer
Flame Photometer
Scanning Spectrophotometer
Turbidity Meters
Grating Spectrophotometer
NIR Spectrophotometer
Colorimeter
Hazemeter
Portable Refractometer
Polarimeters
Vein Finder
lsothermal Amplification System
Molecular Biology Instruments
Molecular Biology Instrument
Colony Counter
Mouth Mirror
Real-time Fluorescence Quantitative PCR Detection System
Manual Rotary Microtome
Fully Automatic Microtome
Floatation Workstation
Semi-Automated Rotary Microtome
Semi-Automatic Microtome
Cryostat Microtome
Rotary Microtome
Vibrating Microtome
Hematology reagent Diluent
Blood Collection Tube
PRP Tube
Medical Consumables
Electrolyte Analyzer
Fully Automatic Urinalysis Analyzer
Semi-Automatic Urinalysis Analyzer
Urine Analyzer
Fluorometer
Pathology Lab Solution
Slide Stainer
Coagulation Analyzer
Auto Coagulation Analyzer
Semi-auto Coagulation Analyzer
Ultra Water Purifier(Synthesizing)
Ultra Water Purifier(Physicochemical)
High Pure Water Purifier
Water Purifier
Ultra Water Purifier(Eliminating endotoxin)
Ultra Water Purifier(Low TOC)
Deionized Water Purifier
Patient Monitor
Pocket pH Tester
Portable pH/ORP Meter
Online pH Meter
Bluetooth Pocket pH/Conductivity Meter
Electrochemistry & Titration
Benchtop pH/Ion Meter
Portable PH Meter
Benchtop pH Meter
PH Electrode
Hemoglobin Analysis Meter
Liquid Chromatograph
ESR Analyzer
Digital Viscometer
Automatic Egg Incubator
Ultrasonic Cleaner
Constant Temperature and Humidity Incubator
Benchtop Constant-Temperature Incubator
Microwave Digestion System
Electronic Analytical Balance(Touch panel,Internal Calibration)
Homogenizer
Horizontal Laminar Flow Cabinet
Tablet Hardness Tester
Biological Safety Cabinet
IVC Cage
Balance
Block Heater
IVC System
Medicine Stability Testing Chamber
Laminar Flow Cabinet
Total Organic Carbon Analyzer
Liquid Dispenser
Automatic Glassware Washer
Thermal Cycler
Semi-micro Analytical Balance
Electronic Balance
Dispensing Booth
Constant-Temperature Incubator
Snowflake Ice Maker
Climate Incubator
Pipette
Tablet Friabilty Tester
Halogen Moisture Analyzer
Viscosity Bath
Fully Automatic Sample Digestion System
Bullet Ice Maker
Clarity Tester
Hospital Furniture
Isolator
Automatic decapper
Lighting Incubator
Vertical Laminar Flow Cabinet
Acid And Alkali Storage Cabinet
Cooling Biochemical Incubator/BOD Incubator
Plant Growth Chamber
Electronic Analytical Balance (Internal Calibration)
Liquid Vacuum Aspiration
Sample Concentrator
Density Meter
Disintegration Tester
Stackable CO2 IncubatorTemperature Shaking Incubator
Hydrostatic balance
Graphite Digester
Electronic Analytical Balance (External Calibration)
Tablet Thickness Tester
Stackable CO2 Incubator
Constant Temperature Shaking Incubator(Benchtop)
Chemical Safety Cabinet
In Situ Hybridization
Horizontal Shaking Incubator
Density Balance
Shaking Incubator
Dissolution Tester
Microplate Washer
Mould Incubator
CO2 Incubator
Elisa Microplate Reader
Fume Hood
Water Hardness Meters
Conductivity Meters
Ion Meters
COD Analyzer
ORP Meters
Salinity Meters
Multiparameter Meters
TDS Meters
Pocket PH Meter
Chlorine Meter
Dissolved Oxygen Meters
Benchtop PH Meter
Titrator
Sieve Shaker
Otoscope
Thermostatic Shaking Water Bath
High Precision Low-Temperature Thermostatic Bath
Thermostatic Magnetic Stirring Bath
Thermostatic Water Bath
Transparent Water Bath
Thermostatic Water Tank
Anaerobic Jar
Anaerobic Incubator
Tissue Processor
Paraffin Dispenser
Digital Pathology Slide Scanner
Paraffin Trimmer
Slide Cabinet
Slide Dryer
Tissue Flotation Water Bath
Inner Core of Electrophoresis Tank
Sequencing Electrophoresis Tank
Electrophoresis Cell
Vertical Electrophoresis Tank
Automatic Gel Imaging and Analysis System
Transilluminator
Horizontal Electrophoresis Tank
Transfer Electrophoresis Tank
Automatic Chemiluminescence Gel Imaging System
Electrophoresis Power Supply
Inverted Microscope
Stereoscopic Microscope
LCD Digital Microscope
Multi-view Microscope
Metallurgical Microscope
Biological Microscope
Fluorescence Microscope
Digital Microscope
Polarizing Micrscope
Reading microscope
Teaching microscope
Blood Cell Counter
Gas Chromatograph
ECG Machine
Blood Plasma Extractor
Blood Collection Monitor
Mini Laboratory Refrigerator
Freezer Boxes
Upright Freezer
Solar Refrigerator
Portable Refrigerator
Car Refrigerator
Double Door Laboratory Refrigerator
Combination Freezer
Tuna Freezer
Corpse Refrigerator
Blood Bank Refrigerator
Portable Ultra-low Temperature Freezer
Ultra Low Temperature Freezer
Single Door Laboratory Refrigerator
PRP Centrifuge
Gel Card Centrifuge
Hematocrit Centrifuge
Benchtop Low Speed High Capacity Centrifuge
Multi Purpose Centrifuges
Low speed Clinical Centrifuge
Benchtop High Speed Centrifuge
Cell Washer/Serofuge Centrifuge
Microplate Centrifuge
Crude Oil Centrifuge
Benchtop Low Speed Centrifuge
Mini Centrifuge
Oil Test Centrifuge
Benchtop Low Speed High Capacity Refrigerated Centrifuge
High Speed Micro Centrifuge
High Speed Mini Centrifuge
Benchtop High Speed Micro Refrigerated Centrifuge
Fat Transplantation Centrifuge
Cyto Centrifuge
Floor-standing High Speed Refrigerated Centrifuge
Low Speed Centrifuge
Benchtop High Speed Refrigerated Centrifuge
Refrigerated and Heating Circulator
Low-temperature constant temperature bath
Thermostatic baths and circulators
Vacuum Controller
Evaporation System
Medical Temperature Controller Device
Low Temperature Circulator
Rotary Evaporator System
Dynamic Temperature Control System
Medical Device
Freezing Point Osmometer
Livifitup Endurance Portable Trainer
Benchtop/Hand-held Eye Wash
Wall-mounted Shower&Eye Wash
Floor-mounted Emergency Eye Wash
Combined Emergency Shower&Eye Wash
Eye Washer
Portable Emergency Eye Wash
Rotary Evaporator
Cooling Circulator
Low temperature cooling liquid circulator
Constant Temperature Drying Oven
Infrared Fast Heating Drying Oven
Vacuum Oven
Forced Air Drying Oven
Big Forced Air Drying Oven
Horizontal Drying Oven(Natural Convection)
Drying Oven/Incubator(Dual-use)
Benchtop Constant-Temperature Drying Oven
Oil-free Vacuum Suction Filter Pump
Water Circulating Vacuum Pump
Manifolds Vacuum Filtration
Chemical Resistant Vacuum Pump
Rotary Slice Vacuum Pump
Diaphragm Vacuum Pump
Microplate Incubator Shaker
Vortex Mixer
Digital Display Heating Mantle
Linear Shaker
Aluminum Hotplate
3D Shaker
Three- layer Shaker
Orbital Shaker
Wrist Shaker
Microplate Mixer
Hotplate Magnetic Stirrer
Digital & Magnetic Stirring Heating Mantles
Stainless Steel Hotplate
Roller Mixer
Rocking Rotator
Rocking Shaker
Multi-position Magnetic Stirrer
Double-layer Shaker
Mini Magnetic Stirrer
Electronic Heating Mantle
Multi-tube Vortexer
Overhead Stirrer
Multi-row Electronic Control Heating Mantle
Heating Mantle
Multi-row Magnetic Stirring Heating Mantles
Electronic Magnetic Stirring Heating Mantle
Single-layer Shaker
Glass Ceramic Hotplate
Microplate Shaker
Magnetic Stirrer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device