Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009526336

FEI Number

3009526336

Entity Name

DELTA INTERNATIONAL TRADE ASIA PACIFIC LTD.

City/State/Country

Kowloon, HK

Establishment Address

28 Shanghai St., Hang Bong Comm. Ctr. Room 101, Kowloon 99999, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Delta International Trade Asia Pacific Ltd. (Owner Number: 10039497)

Owner / Operator Contact Address

28 Shanghai St., Hang Bong Comm. Ctr. Room 101, Kowloon, HK-NOTA 99999, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152643

PMA Number

N/A

All Registered Proprietary Names

Ovulation Predictor Kit Gauze LSS Pregnancy Test Kit Drug Test Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2016-12-16
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2016-12-21
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2022-12-09
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2016-12-21
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2016-12-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2012-01-16
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2016-12-21
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2016-12-21

Official Correspondent

Frank Lin

US Agent Details

Mark M. Yesil Business: Delta Brands Inc. Email: reg@deltabrands.com Phone: (914) 8331700

Related Public Records

Same Entity

Delta International Trade Asia Pacific 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
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
K904016	Bhc Biotech , Ltd.	MAXI TEST	1990-10-15
K870259	Leeco Diagnostics, Inc.	VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044	1987-03-10
K820822	Hybritech, Inc.	TANDEM HCG KIT	1982-04-29
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01

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3027500452	TRUE DIAGNOSTICS, INC.	Carlsbad, CA, US
3013885851	CENTUM ELECTRONICS LIMITED	Bangalore Karnataka, IN
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009526336. Last updated year: 2026. Please use registration number 3009526336 when referencing this establishment in official correspondence.