FDA 510(k)

BIO-UREA

K-Number: K834029 · 1983-12-30

Decision Date1983-12-30

Product CodeJTO

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BIO-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 1983-12-30 under 510(k) number K834029. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-UREA?

BIO-UREA is a medical device that received FDA 510(k) clearance on 1983-12-30. The listed applicant is Remel Co.. The 510(k) number is K834029.

When did BIO-UREA receive FDA 510(k) clearance?

BIO-UREA received FDA 510(k) clearance on 1983-12-30, under 510(k) number K834029.

Who is the listed applicant for BIO-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 BIO-UREA?

The FDA product code for BIO-UREA is JTO.

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 DRY K965151A.C.T. III K965150A.C.T. IV K965152A.C.T. II K965149A.C.T. I K960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: JTO)

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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.