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FDA 510(k)

MISSION U500 URINE ANALYZER

K-Number: K111221 · 2012-01-18

ApplicantACON Laboratories, Inc.
Decision Date2012-01-18
Product CodeJIO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MISSION U500 URINE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is ACON Laboratories, Inc.. It received FDA 510(k) clearance on 2012-01-18 under 510(k) number K111221. The device is classified under product code JIO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISSION U500 URINE ANALYZER?

MISSION U500 URINE ANALYZER is a medical device that received FDA 510(k) clearance on 2012-01-18. The listed applicant is ACON Laboratories, Inc.. The 510(k) number is K111221.

When did MISSION U500 URINE ANALYZER receive FDA 510(k) clearance?

MISSION U500 URINE ANALYZER received FDA 510(k) clearance on 2012-01-18, under 510(k) number K111221.

Who is the listed applicant for MISSION U500 URINE ANALYZER?

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

What is the FDA product code for MISSION U500 URINE ANALYZER?

The FDA product code for MISSION U500 URINE ANALYZER is JIO.

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Related Devices (Code: JIO)

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K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd.K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALHealgen Scientific,, LLCK082811URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERSUrit Medical Electronic Co., Ltd.K083724WIENER LAB. URINE STRIP 10 AND 11Wiener Laboratorios SaicK040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSISDirui Industrial Co., Ltd.K023297URS-1B (BLOOD TEST)Teco Diagnostics

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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