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FDA 510(k)

URINE REAGENT STRIP-3 PARAMETERS

K-Number: K940469 · 1994-09-09

ApplicantTeco Diagnostics
Decision Date1994-09-09
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE REAGENT STRIP-3 PARAMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1994-09-09 under 510(k) number K940469. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE REAGENT STRIP-3 PARAMETERS?

URINE REAGENT STRIP-3 PARAMETERS is a medical device that received FDA 510(k) clearance on 1994-09-09. The listed applicant is Teco Diagnostics. The 510(k) number is K940469.

When did URINE REAGENT STRIP-3 PARAMETERS receive FDA 510(k) clearance?

URINE REAGENT STRIP-3 PARAMETERS received FDA 510(k) clearance on 1994-09-09, under 510(k) number K940469.

Who is the listed applicant for URINE REAGENT STRIP-3 PARAMETERS?

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 URINE REAGENT STRIP-3 PARAMETERS?

The FDA product code for URINE REAGENT STRIP-3 PARAMETERS is JIL.

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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: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

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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