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FDA 510(k)

URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)

K-Number: K955438 · 1996-01-29

ApplicantTeco Diagnostics
Decision Date1996-01-29
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 1996-01-29 under 510(k) number K955438. The device is classified under product code JIR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)?

URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-01-29. The listed applicant is Teco Diagnostics. The 510(k) number is K955438.

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

URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) received FDA 510(k) clearance on 1996-01-29, under 510(k) number K955438.

Who is the listed applicant for URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)?

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 STRIPS-3 PARAMETERS (MODIFICATION)?

The FDA product code for URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) is JIR.

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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

View all 49 devices →

Related Devices (Code: JIR)

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.

K222921Minuteful-kidney testHealthy.Io, Ltd.K210069Minuteful - kidney testHealthy.Io, Ltd.K061419TECO MICROALBUMIN 2-1 COMBO STRIPSTeco DiagnosticsK022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25Diagnostic Chemicals, Ltd. (Usa)K001810URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTINGFlexsite Diagnostics, Inc.K994035IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15Diagnostic Chemicals , 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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