Chong Qing Teco Huayi Pharm. Co.

Registration Details

Registration Name: Chong Qing Teco Huayi Pharm. Co.
Registration Number: 3006621318
FEI Number: 3006621318
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 1st Std. Workshop 2-402, No. 98, Xiyuan 2nd Road, Shapingba Dist., Chongqing 401332
City: Shapingba Dist., Chongqing
Country: CN

Regulatory Submissions

510(k) Number: K150063

Owner / Operator

Firm Name: TECO DIAGNOSTICS
Operator Number: 1832216
Address: 1268 NORTH LAKEVIEW AVE., --
City: Anaheim
State: CA
Postal Code: 92807
Country: US
Correspondent: KC Chen

US Agent

Business Name: Teco Diagnostics
Contact Name: KC Chen
Address: 1268 N. Lakeview Ave
City: Anaheim
State: CA
ZIP: 92807
Country: US
Email: [email protected]
Phone: 714 4631111

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Kit, Test, Pregnancy, Hcg, Over The Counter	LCX	Class 2	Clinical Chemistry	No	2025-08-14
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	Class 1	Clinical Chemistry	No	2006-12-28
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	JIL	Class 2	Clinical Chemistry	No	2011-02-16
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	JIR	Class 1	Clinical Chemistry	No	2011-02-16
Automated Urinalysis System	KQO	Class 1	Clinical Chemistry	No	2011-02-16
Refractometer For Clinical Use	JRE	Class 1	Clinical Chemistry	No	2011-02-16
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	Class 1	Clinical Chemistry	No	2011-02-16
Test, Urine Leukocyte	LJX	Class 1	Hematology	No	2011-02-16
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	Class 1	Clinical Chemistry	No	2011-02-16
Nitroprusside, Ketones (Urinary, Non-Quant.)	JIN	Class 1	Clinical Chemistry	No	2011-02-16
Blood, Occult, Colorimetric, In Urine	JIO	Class 2	Hematology	No	2011-02-16
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	Class 1	Clinical Chemistry	No	2011-02-16
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	Class 1	Clinical Chemistry	No	2011-02-16
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	Class 1	Clinical Chemistry	No	2006-11-06
Visual, Pregnancy Hcg, Prescription Use	JHI	Class 2	Clinical Chemistry	No	2009-03-02
Reagent, Occult Blood	KHE	Class 2	Hematology	No	2006-12-28
Enzymatic Method, Creatinine	JFY	Class 2	Clinical Chemistry	No	2016-04-20
Electrolyte Controls (Assayed And Unassayed)	JJR	Class 1	Clinical Chemistry	No	2009-03-02

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 URS-1K URITEK TC-201 URINE CHEMISTRY TEST SYSTEM ONE STEP PREGNANCY CARD TEST Uritek TC-201 Urine Chemistry Test System Cliawaived 10SG URS-5OB-100 URS-2P-100 URS-10

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility