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FDA 510(k)

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50

K-Number: K993178 · 1999-10-18

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1999-10-18
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1999-10-18 under 510(k) number K993178. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50?

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 is a medical device that received FDA 510(k) clearance on 1999-10-18. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K993178.

When did UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 receive FDA 510(k) clearance?

UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 received FDA 510(k) clearance on 1999-10-18, under 510(k) number K993178.

Who is the listed applicant for UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50?

The FDA product code for UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 is CDQ.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

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Related Devices (Code: CDQ)

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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