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FDA 510(k)

URS-IG (GLUCOSE TEST)

K-Number: K020175 · 2002-03-21

ApplicantTeco Diagnostics
Decision Date2002-03-21
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URS-IG (GLUCOSE TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Teco Diagnostics. It received FDA 510(k) clearance on 2002-03-21 under 510(k) number K020175. 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 URS-IG (GLUCOSE TEST)?

URS-IG (GLUCOSE TEST) is a medical device that received FDA 510(k) clearance on 2002-03-21. The listed applicant is Teco Diagnostics. The 510(k) number is K020175.

When did URS-IG (GLUCOSE TEST) receive FDA 510(k) clearance?

URS-IG (GLUCOSE TEST) received FDA 510(k) clearance on 2002-03-21, under 510(k) number K020175.

Who is the listed applicant for URS-IG (GLUCOSE TEST)?

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 URS-IG (GLUCOSE TEST)?

The FDA product code for URS-IG (GLUCOSE TEST) 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)

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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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