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FDA 510(k)

URYXXON RELAX URINE ANALYZER

K-Number: K061742 · 2006-09-06

ApplicantMacherey-Nagel GmbH & Co. KG
Decision Date2006-09-06
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URYXXON RELAX 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 2006-09-06 under 510(k) number K061742. 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 RELAX URINE ANALYZER?

URYXXON RELAX URINE ANALYZER is a medical device that received FDA 510(k) clearance on 2006-09-06. The listed applicant is Macherey-Nagel GmbH & Co. KG. The 510(k) number is K061742.

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

URYXXON RELAX URINE ANALYZER received FDA 510(k) clearance on 2006-09-06, under 510(k) number K061742.

Who is the listed applicant for URYXXON RELAX 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 RELAX URINE ANALYZER?

The FDA product code for URYXXON RELAX 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.

K051034URYXXON 200 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.

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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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