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FDA 510(k)

TECO MICROALBUMIN 2-1 COMBO STRIPS

K-Number: K061419 · 2007-01-26

ApplicantTeco Diagnostics
Decision Date2007-01-26
Product CodeJIR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECO MICROALBUMIN 2-1 COMBO STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2007-01-26 under 510(k) number K061419. 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 TECO MICROALBUMIN 2-1 COMBO STRIPS?

TECO MICROALBUMIN 2-1 COMBO STRIPS is a medical device that received FDA 510(k) clearance on 2007-01-26. The listed applicant is Teco Diagnostics. The 510(k) number is K061419.

When did TECO MICROALBUMIN 2-1 COMBO STRIPS receive FDA 510(k) clearance?

TECO MICROALBUMIN 2-1 COMBO STRIPS received FDA 510(k) clearance on 2007-01-26, under 510(k) number K061419.

Who is the listed applicant for TECO MICROALBUMIN 2-1 COMBO STRIPS?

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 TECO MICROALBUMIN 2-1 COMBO STRIPS?

The FDA product code for TECO MICROALBUMIN 2-1 COMBO STRIPS 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

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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.K022538IMMUNODIP 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.K992257NEW MULTIPLES REAGENT STRIPSBayer Corp.

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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