Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006621318

FEI Number

3006621318

Entity Name

Chong Qing Teco Huayi Pharm. Co.

City/State/Country

Shapingba Dist., Chongqing, CN

Establishment Address

1st Std. Workshop 2-402, No. 98, Xiyuan 2nd Road, Shapingba Dist., Chongqing 401332, Shapingba Dist., Chongqing 401332, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TECO DIAGNOSTICS (Owner Number: 1832216)

Owner / Operator Contact Address

1268 NORTH LAKEVIEW AVE., --, Anaheim, CA 92807, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K964536

PMA Number

N/A

All Registered Proprietary Names

Pregnancy HCG test midstream TC-3300 Analyzer system URITEK TC-101 URINE ANALYZER TC-84+ Analyzer system TC-84 analyzer system One-step urine/serum pregnancy card test URITEK-720+ URINE ANALYZER TC-96 Analyzer system Teco Rapid Fecal Occult Blood (FOB) Card Test TC-Thunderbolt automated urine analyzer system One-step combo pregnancy dipstick test ONE-STEP DIPSTICK PREGNANCY TEST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-08-14
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2006-12-28
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2011-02-16
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2011-02-16
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2011-02-16
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2011-02-16
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2011-02-16
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2011-02-16
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2011-02-16
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2011-02-16
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2011-02-16
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2011-02-16
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2011-02-16
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2006-11-06
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2009-03-02
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2009-03-02
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2009-03-02
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2009-03-02
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2009-03-02
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2009-03-02
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2009-03-02
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2009-03-02
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2009-03-02
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2009-03-02
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2009-03-02
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2009-03-02
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2009-03-02
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2009-03-02
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2006-12-28
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2015-11-04
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2015-11-04
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2015-11-04
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2015-11-04
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2015-11-04
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2015-11-04
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2015-11-04
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2015-11-04
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2015-11-04
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2015-11-04
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2015-11-04
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2009-03-02
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2009-03-02

Official Correspondent

KC Chen

US Agent Details

KC Chen Business: Teco Diagnostics Email: hello@tecodiagnostics.com Phone: (714) 4631111

Related Public Records

Same Entity

TECO DIAGNOSTICS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1832216	TECO DIAGNOSTICS	ANAHEIM, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K964536	Teco Diagnostics	ONE-STEP DIPSTICK PREGNANCY TEST	1997-02-11
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
Z-0081-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
Z-0082-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
Z-0083-2015	Siemens Healthcare Diagnostics, Inc	2	External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.

Similar Registrations

Registration Number	Establishment Name	Location
1051594	CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.)	MORRISTOWN, TN, US
3007583565	SPD DEVELOPMENT COMPANY LIMITED	Bedford, GB
3012725363	EASY HEALTHCARE CORPORATION	Darien, IL, US
1649661	GERMAINE LABORATORIES, INC.	SAN ANTONIO, TX, US
3003741676	ANDON HEALTH CO., LTD	TIANJIN, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006621318. Last updated year: 2026. Please use registration number 3006621318 when referencing this establishment in official correspondence.