Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043138885

FEI Number

3043138885

Entity Name

LABPEAK CO.,LTD

City/State/Country

Jinan Shandong, CN

Establishment Address

Room 4, Building 5, Jinan Biomedical Zone, No. 30766 Jingshi East Road, Jinan, Shandong, China., 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

Labpeak Co.,Ltd (Owner Number: 10094757)

Owner / Operator Contact Address

Room 4, Building 5, Jinan Biomedical Zone, No. 30766 Jingshi East Road, Jinan, Shandong, China., 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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2025-12-21
KZA	Device, Vein Location, Liquid Crystal	General Hospital	Class 1	880.6970	2025-12-21
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2026-02-09
KZB	Automated Colony Counter	Microbiology	Class 1	866.2170	2025-12-21
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2025-12-21
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2025-12-21
IDP	Microtome, Cryostat	Pathology	Class 1	864.3010	2025-12-21
GIF	Diluent, Blood Cell	Hematology	Class 1	864.8200	2025-12-21
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2025-12-21
JJP	Electrode, Ion Selective (Non-Specified)	Clinical Chemistry	Class 1	862.2050	2025-12-21
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2025-12-21
JZT	Fluorometer	Immunology	Class 1	866.4520	2025-12-21
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2025-12-21
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2025-12-21
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2025-12-21
IWE	Monitor, Patient Position, Light-Beam	Radiology	Class 1	892.5780	2025-12-21
JQY	Ph Meter	Clinical Chemistry	Class 1	862.2050	2025-12-21
GGF	Acid Hematin	Hematology	Class 2	864.7500	2025-12-21
LDM	Instrumentation, High Pressure Liquid Chromatography	Clinical Chemistry	Class 1	862.2260	2025-12-21
GKB	Device, Automated Sedimentation Rate	Hematology	Class 1	864.5800	2025-12-21
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2025-12-21
DOP	Mass Spectrometer, Clinical Use	Clinical Chemistry	Class 1	862.2860	2025-12-21
IDX	Sieves, Tissue	Pathology	Class 1	864.3010	2025-12-21
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2025-12-21
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2025-12-21
KZJ	Device, Gas Generating	Microbiology	Class 1	866.2580	2025-12-21
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2025-12-21
JJN	Apparatus, Electrophoresis, For Clinical Use	Clinical Chemistry	Class 1	862.2485	2025-12-21
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2025-12-21
GHO	Hemocytometer	Hematology	Class 1	864.6160	2025-12-21

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

Labpeak 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
K760211	Instrumentation Laboratory CO	ANALYZER, GLUCOSE/UREA/CREATININE	1976-08-26
K101852	Iris International Inc., A Division of Iris Iris I	CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT	2011-03-23
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

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043138885. Last updated year: 2026. Please use registration number 3043138885 when referencing this establishment in official correspondence.