Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010031137

FEI Number

3010031137

Entity Name

Yantai Addcare Bio-Tech Co., Ltd.

City/State/Country

Yantai Shandong, CN

Establishment Address

No.10, Nanjing Street, Development Zone, Yantai Shandong 265501, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Yantai Addcare Bio-Tech Co., Ltd. (Owner Number: 10054662)

Owner / Operator Contact Address

No.10, Nanjing Street, Development Zone, Yantai, CN-SD 265501, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vacuum Tube Labeling System Rodeman Microplate washer iWash8/12 Automated Medical Laboratory Workflow Platform LineTo-3000C, LineTo-2000D Automated Medical Laboratory Workflow Platform Flow Fluore 200, LineTo-5000 Semi-automatic Gelcard incubator R-24C Fully Automated FIA Analyzer(ADC FIA 800,ADC FIA 600,ADC FIA 400,ADC FIA 200) Centrifuge(NJ-24, NJ-12, AC-80) Fully Automated Nucleic Acid Extractor; NA4048,NA4424,NA4316,NA2316,NA2324,NA2224,NA1116,NA1216; Nexor 32M, Nexor 32 Nexor 96, ADC CH616, ADC CH196 Fully Automated Nucleic Acid Extractor NA2288 ELISA Reader DM 880L ADC CLIA 800,ADC CLIA 600,ADC CLIA 500,ADC CLIA 400,ADC CLIA 300,ADC CLIA 200 Chemiluminescence Reader JUDE 96 Fully Automated CLIA workstation iTube 3000, iTube 5000 ELISA Reader DM 801, DM 801B Fully Automated Biochemistry Analyzer BC-400, BC-600, BC-2000 Fully Automated CLIA Workstation iTube 1000 Fully Automated CLIA and ELISA Workstation ICE 800, ICE 400 Fully automated blood grouping system Blozer 200, Blozer 150, Blozer 120, Blozer 100, Blozer 72

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2019-12-10
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2019-12-10
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2017-04-12
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2017-04-12
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2022-02-21
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-04-12
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2019-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Jessie Yao Email: info@medright-tech.com Phone: (718) 2169957

Related Public Records

Same Entity

Yantai Addcare Bio-Tech 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
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K760211	Instrumentation Laboratory CO	ANALYZER, GLUCOSE/UREA/CREATININE	1976-08-26

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-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010031137. Last updated year: 2026. Please use registration number 3010031137 when referencing this establishment in official correspondence.