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FDA 510(k)

URINE CHEMISTRY ANALYZER UR-50

K-Number: K063390 · 2007-03-01

ApplicantInd Diagnostic, Inc.
Decision Date2007-03-01
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE CHEMISTRY ANALYZER UR-50 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 2007-03-01 under 510(k) number K063390. 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 CHEMISTRY ANALYZER UR-50?

URINE CHEMISTRY ANALYZER UR-50 is a medical device that received FDA 510(k) clearance on 2007-03-01. The listed applicant is Ind Diagnostic, Inc.. The 510(k) number is K063390.

When did URINE CHEMISTRY ANALYZER UR-50 receive FDA 510(k) clearance?

URINE CHEMISTRY ANALYZER UR-50 received FDA 510(k) clearance on 2007-03-01, under 510(k) number K063390.

Who is the listed applicant for URINE CHEMISTRY ANALYZER UR-50?

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 URINE CHEMISTRY ANALYZER UR-50?

The FDA product code for URINE CHEMISTRY ANALYZER UR-50 is JIL.

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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.

K103037IND URINARY TRACT INFECTION (UTI) TEST STRIPSK100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10K060810ONE 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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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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