BEUDAMED

FDA Registration Active 🇺🇸 United States

URITEK TC-101 URINE ANALYZER

Reg #: 1832216 · FEI: 1832216 · Expires 2025

Products

11

Proprietary Names

1

Establishment Types

1

Classifications

11

Registration Details

Registration Name: TECO DIAGNOSTICS
Registration Number: 1832216
FEI Number: 1832216
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 1268 NORTH LAKEVIEW AVE.
City: ANAHEIM
State: CA
ZIP: 92807
Country: US

Regulatory Submissions

510(k) Number: K101673

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

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
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
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	JMT	Class 1	Clinical Chemistry	No	2011-02-16
Dye-Indicator, Ph (Urinary, Non-Quantitative)	CEN	Class 1	Clinical Chemistry	No	2011-02-16
Test, Urine Leukocyte	LJX	Class 1	Hematology	No	2011-02-16
Refractometer For Clinical Use	JRE	Class 1	Clinical Chemistry	No	2011-02-16
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	CDM	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
Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	JJB	Class 1	Clinical Chemistry	No	2011-02-16

Proprietary Names

URITEK TC-101 URINE ANALYZER

Establishment Types

Manufacture Medical Device