Data / Medical devices / China / Shenzhen Yhlo Biotech Co., Ltd.

Shenzhen Yhlo Biotech Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance

Name: Shenzhen Yhlo Biotech Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Shenzhen Yhlo Biotech Co., Ltd. is registered with the FDA (registration 3017019647) in Shenzhen Guangdong, China. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 11, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Shenzhen Yhlo Biotech Co., Ltd.

FDA registration number: 3017019647
Address: Building 1, YHLO Biopark, Baolong 2nd Road, Baolong Subdistrict, Longgang District, Shenzhen Guangdong, China, 518116
Owner or operator: SHENZHEN YHLO BIOTECH CO., LTD. (10082247)
Roles: Manufacturer
First device listed: June 28, 2022
Registered through: 2026
Brand names listed: Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C), Chemiluminescence Immunoassay Analyzer; iFlash 1200-A, Chemiluminescence Immunoassay Analyzer; iFlash 1800-A, Chemiluminescence Immunoassay Analyzer; iFlash 3000-C, I-UNICELL Incubator, Immunofluorescence Reader, Pre-Trigger Solution (1X); Specification: 900mL*4 bottles, 500mL*4 bottles, 220mL*4 bottles, Reaction Vessel and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Antisera, All Mycoplasma Spp.	GSA	1	Manufacturer	accessdata.fda.gov
Cuvette, Thermostated	JRI	1	Manufacturer	accessdata.fda.gov
Device, Automated Sedimentation Rate	GKB	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer	accessdata.fda.gov
Radioassay, Triiodothyronine Uptake	KHQ	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Thyroxine	CDX	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer	accessdata.fda.gov
System, Test, Human Chorionic Gonadotropin	DHA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 11, 2023	K223690	iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)	DHA	Substantially Equivalent	Shenzhen Yhlo Biotech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 11, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.