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FDA 510(k)

IND URINARY TRACT INFECTION (UTI) TEST STRIPS

K-Number: K103037 · 2012-04-17

ApplicantInd Diagnostic, Inc.
Decision Date2012-04-17
Product CodeNGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IND URINARY TRACT INFECTION (UTI) TEST STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Ind Diagnostic, Inc.. It received FDA 510(k) clearance on 2012-04-17 under 510(k) number K103037. The device is classified under product code NGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IND URINARY TRACT INFECTION (UTI) TEST STRIPS?

IND URINARY TRACT INFECTION (UTI) TEST STRIPS is a medical device that received FDA 510(k) clearance on 2012-04-17. The listed applicant is Ind Diagnostic, Inc.. The 510(k) number is K103037.

When did IND URINARY TRACT INFECTION (UTI) TEST STRIPS receive FDA 510(k) clearance?

IND URINARY TRACT INFECTION (UTI) TEST STRIPS received FDA 510(k) clearance on 2012-04-17, under 510(k) number K103037.

Who is the listed applicant for IND URINARY TRACT INFECTION (UTI) TEST STRIPS?

The FDA 510(k) record lists Ind Diagnostic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IND URINARY TRACT INFECTION (UTI) TEST STRIPS?

The FDA product code for IND URINARY TRACT INFECTION (UTI) TEST STRIPS is NGJ.

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Other records listing Ind Diagnostic, Inc. 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.

K100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10K063390URINE CHEMISTRY ANALYZER UR-50K060810ONE STEP DRUG TEST - AMP/MET/MOR/THC/COCK052694ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.K052662ONE STEP FSH MENOPAUSAL TESTK050741IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT

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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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