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FDA 510(k)

UREA BROTH

K-Number: K881560 · 1988-04-18

Decision Date1988-04-18
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

UREA BROTH is the device name listed in this FDA 510(k) record. The listed applicant is Acumedia Manufacturers, Inc.. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K881560. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA BROTH?

UREA BROTH is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Acumedia Manufacturers, Inc.. The 510(k) number is K881560.

When did UREA BROTH receive FDA 510(k) clearance?

UREA BROTH received FDA 510(k) clearance on 1988-04-18, under 510(k) number K881560.

Who is the listed applicant for UREA BROTH?

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

What is the FDA product code for UREA BROTH?

The FDA product code for UREA BROTH is JSH.

Related Clinical Trials

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.

Other records listing Acumedia Manufacturers, Inc. 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.

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Related Devices (Code: JSH)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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