Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015972771

FEI Number

3015972771

Entity Name

HUMAN METABOLOMICS INSTITUTE, INC.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Suite 501D1, Building E, Gangzhilong Science and Technology Park, No.6 Qinglong Road, Qinghua Community, Longhua District, Shenzhen Guangdong 518109, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Human Metabolomics Institute, Inc. (Owner Number: 10061371)

Owner / Operator Contact Address

Suite 501D1, Building E, Gangzhilong Science and Technology Park, No.6 Qinglong Road, Qinghua Community, Longhua District, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

25-OH Vitamin D Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry) L-Tyrosine and Taurocholic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry) Amino Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry) Monoconjugated Bilirubin Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry) Liver Fibrosis and Cirrhosis Risk Assessment Software Liver Steatosis Risk Assessment Software Chronic Liver Disease Risk Assessment Software Type 2 Diabetes Risk Assessment Software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2021-11-03
JKW	N-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin	Clinical Chemistry	Class 1	862.1180	2019-10-12
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2021-11-04
PQQ	Data Acquisition Software	Clinical Chemistry	Class 2	862.2570	2019-10-12

Official Correspondent

Yue Chen

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Human Metabolomics Institute, Inc.

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
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015972771. Last updated year: 2026. Please use registration number 3015972771 when referencing this establishment in official correspondence.