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FDA 510(k)

URYXXON 200 URINE ANALYZER

K-Number: K051034 · 2005-11-22

ApplicantMacherey-Nagel GmbH & Co. KG
Decision Date2005-11-22
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URYXXON 200 URINE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Macherey-Nagel GmbH & Co. KG. It received FDA 510(k) clearance on 2005-11-22 under 510(k) number K051034. 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 URYXXON 200 URINE ANALYZER?

URYXXON 200 URINE ANALYZER is a medical device that received FDA 510(k) clearance on 2005-11-22. The listed applicant is Macherey-Nagel GmbH & Co. KG. The 510(k) number is K051034.

When did URYXXON 200 URINE ANALYZER receive FDA 510(k) clearance?

URYXXON 200 URINE ANALYZER received FDA 510(k) clearance on 2005-11-22, under 510(k) number K051034.

Who is the listed applicant for URYXXON 200 URINE ANALYZER?

The FDA 510(k) record lists Macherey-Nagel GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URYXXON 200 URINE ANALYZER?

The FDA product code for URYXXON 200 URINE ANALYZER is JIL.

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Other records listing Macherey-Nagel GmbH & Co. KG 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.

K061742URYXXON RELAX URINE ANALYZER

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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