Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013735968

FEI Number

3013735968

Entity Name

SMILELAB CO., LTD.

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

RB-106, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu,, Seongnam-si, Gyeonggi-do, Republic of Korea, Seongnam-si Gyeonggi 13211, KR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Remanufacture Medical Device,Reprocess Single-Use Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor,Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Smilelab Co., Ltd. (Owner Number: 10055410)

Owner / Operator Contact Address

RB-106, 33, Sagimakgol-ro 62beon-gil, Jungwon-gu,, Seongnam-si, KR-41 13211, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PREGABLE ovulation&pregnancy test kit (PREGABLE PREGNANCY TEST) PREGABLE ovulation&pregnancy test kit (PREGABLE PREGNANCY TEST)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2025-02-03
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-02-03
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2017-07-20

Official Correspondent

YOUNGHUN SONG

US Agent Details

Kyou Hee Lee Email: overseas@smilelab.co.kr Phone: (608) 7705379

Related Public Records

Same Entity

Smilelab 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
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-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
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01

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2027969	Alere San Diego, Inc.	San Diego, CA, US
1222302	American Laboratory Products Company	Salem, NH, US
2032364	VICTORCH MEDITEK, INC.	San Diego, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013735968. Last updated year: 2026. Please use registration number 3013735968 when referencing this establishment in official correspondence.