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FDA 510(k)

URITEK 151 URINE ANALYZER, MODEL TC-151

K-Number: K042421 · 2005-05-09

ApplicantTeco Diagnostics
Decision Date2005-05-09
Product CodeKQO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URITEK 151 URINE ANALYZER, MODEL TC-151 is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2005-05-09 under 510(k) number K042421. 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 151 URINE ANALYZER, MODEL TC-151?

URITEK 151 URINE ANALYZER, MODEL TC-151 is a medical device that received FDA 510(k) clearance on 2005-05-09. The listed applicant is Teco Diagnostics. The 510(k) number is K042421.

When did URITEK 151 URINE ANALYZER, MODEL TC-151 receive FDA 510(k) clearance?

URITEK 151 URINE ANALYZER, MODEL TC-151 received FDA 510(k) clearance on 2005-05-09, under 510(k) number K042421.

Who is the listed applicant for URITEK 151 URINE ANALYZER, MODEL TC-151?

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 151 URINE ANALYZER, MODEL TC-151?

The FDA product code for URITEK 151 URINE ANALYZER, MODEL TC-151 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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