Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017019647

FEI Number

3017019647

Entity Name

SHENZHEN YHLO BIOTECH CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, Shenzhen Guangdong 518116, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHENZHEN YHLO BIOTECH CO., LTD. (Owner Number: 10082247)

Owner / Operator Contact Address

Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, Shenzhen, CN-GD 518116, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iFlash-Insulin Reaction Vessel iFlash-T4 iFlash-C-Peptide iFlash-DHEA-S iFlash-Mycoplasma pn. IgM iFlash-Mycoplasma pn. IgG iFlash-FSH VISION ESR Analyzer; VISION-A, VISION-B, VISION-C, VISION Pro-A, VISION Pro-B, VISION Pro-C Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) iFlash-HCG iFlash-Prolactin iFlash-FT3 iFlash-E2 iFlash-Cleaning Solution; Specification: 45mL*2 bottles, 30mL*2 bottles Trigger Solution (1X); Specification: 900mL*4 bottles, 500mL*4 bottles, 220mL*4 bottles Sample Diluent; Model: A, B, E, I, H, G, Specification: 45mL*2 bottles Pre-Trigger Solution (1X); Specification: 900mL*4 bottles, 500mL*4 bottles, 220mL*4 bottles Wash Buffer; Model: Wash Buffer (1X), Specification: 10L; Model: Wash Buffer (10X), Specification: 10L, 1L*4 bottles Sample Diluent; Model: I-1, Specification: 0.57mL*100 PCS Sample Diluent; Model: D, Specification: 120?L*100 PCS Immunofluorescence Reader I-UNICELL Incubator iFlash-hGH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2022-06-29
JRI	Cuvette, Thermostated	Clinical Chemistry	Class 1	862.2050	2022-06-29
CDX	Radioimmunoassay, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2025-12-10
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	Class 1	862.1135	2022-06-29
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2022-06-29
GSA	Antisera, All Mycoplasma Spp.	Microbiology	Class 1	866.3375	2022-06-29
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2022-06-28
GKB	Device, Automated Sedimentation Rate	Hematology	Class 1	864.5800	2022-06-29
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2023-12-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2023-12-20
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2022-06-28
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2022-06-29
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2022-06-29
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2022-06-29
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2022-06-29
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	2022-06-29

Official Correspondent

Dan Wang

US Agent Details

Joe Shia Business: LSI International Inc Email: jxia@lsi-consulting.org Phone: (240) 5057880

Related Public Records

Same Entity

SHENZHEN YHLO BIOTECH 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
K833852	Syncor Intl. Corp.	FSH RIA	1984-01-13
K880678	Ventrex Laboratories, Inc.	MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY	1988-04-05
K072500	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE/SERUM TEST	2009-04-21
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K971921	Monobind	PROLACTIN (PRL) HORMONE MICROPLATE ELISA	1997-06-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-06	Nichols Institute Diagnostics	2	Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
Z-0007-06	Nichols Institute Diagnostics	2	Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
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 3017019647. Last updated year: 2026. Please use registration number 3017019647 when referencing this establishment in official correspondence.