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FDA 510(k)

SELECTIVE RAPID UREA

K-Number: K883641 · 1989-05-04

ApplicantRemel Co.
Decision Date1989-05-04
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SELECTIVE RAPID UREA is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1989-05-04 under 510(k) number K883641. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECTIVE RAPID UREA?

SELECTIVE RAPID UREA is a medical device that received FDA 510(k) clearance on 1989-05-04. The listed applicant is Remel Co.. The 510(k) number is K883641.

When did SELECTIVE RAPID UREA receive FDA 510(k) clearance?

SELECTIVE RAPID UREA received FDA 510(k) clearance on 1989-05-04, under 510(k) number K883641.

Who is the listed applicant for SELECTIVE RAPID UREA?

The FDA 510(k) record lists Remel Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SELECTIVE RAPID UREA?

The FDA product code for SELECTIVE RAPID UREA is LYR.

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Other records listing Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: LYR)

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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