Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025760

FEI Number

2025760

Entity Name

SYNTRON BIORESEARCH, INC.

City/State/Country

CARLSBAD, CA, US

Establishment Address

2774 LOKER AVE. WEST, CARLSBAD, CA 92010, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

SYNTRON BIORESEARCH, INC. (Owner Number: 2025760)

Owner / Operator Contact Address

2774 LOKER AVE. WEST, --, Carlsbad, CA 92010, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K921099

PMA Number

N/A

All Registered Proprietary Names

Ovulation Test, Frida Baby Well At Walgreens Early Result Pregnancy Test Two Samples Well at Walgreens ONE STEP PREGNANCY TEST One Sample Frida Early Detection Pregnancy Test AFIA Early Result Pregnancy Test Well At Walgreens Early Result Pregnancy Test Three Samples Well at Walgreens ONE STEP PREGNANCY TEST Two Samples Well at Walgreens ONE STEP PREGNANCY TEST Three Samples Equate Early Result Pregnancy Test First Response Pregnancy Test Cups SYNTRON QUIKSTRIP/E.Z. STRIP PREGNA

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	2021-07-16
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2018-03-06
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2018-03-06
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-05-23
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2007-10-08

Official Correspondent

Charles Yu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SYNTRON BIORESEARCH, 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
K964108	Direct Access Diagnostics	FACT PLUS PREGNANCY TEST	1996-11-18
K945514	Princeton BioMeditech Corp.	LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG	1995-02-10
K150022	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream	2015-08-07
K043443	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP HCG URINE PREGNANCY TEST	2005-04-08
K173229	Guangzhou Wondfo Biotech Co., Ltd.	Preview Digital Pregnancy Test	2018-03-12

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-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025760. Last updated year: 2026. Please use registration number 2025760 when referencing this establishment in official correspondence.