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FDA 510(k)

URITEK-720+ URINE ANALYZER

K-Number: K051526 · 2005-08-16

ApplicantTeco Diagnostics
Decision Date2005-08-16
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URITEK-720+ URINE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2005-08-16 under 510(k) number K051526. The device is classified under product code KQO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URITEK-720+ URINE ANALYZER?

URITEK-720+ URINE ANALYZER is a medical device that received FDA 510(k) clearance on 2005-08-16. The listed applicant is Teco Diagnostics. The 510(k) number is K051526.

When did URITEK-720+ URINE ANALYZER receive FDA 510(k) clearance?

URITEK-720+ URINE ANALYZER received FDA 510(k) clearance on 2005-08-16, under 510(k) number K051526.

Who is the listed applicant for URITEK-720+ URINE ANALYZER?

The FDA 510(k) record lists Teco Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URITEK-720+ URINE ANALYZER?

The FDA product code for URITEK-720+ URINE ANALYZER is KQO.

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Other records listing Teco Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170118Scanostics UTI Check Application Test SystemK111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTK100024TECO DIAGNOSTICS UTI DETECTION STRIPSK101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERK072548CREATINE KINASE LIQUID REAGENT, MODEL C519-440

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Related Devices (Code: KQO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.K102188CYBOW READER, MODELS 300 & 720DFI Co., Ltd.K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris IK091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.K093555COBAS U411 TEST SYSTEMRoche DiagnosticsK093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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