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FDA 510(k)

UREA NITROGEN-UV

K-Number: K833931 · 1984-01-13

ApplicantSeragen Diagnostics, Inc.
Decision Date1984-01-13
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN-UV is the device name listed in this FDA 510(k) record. The listed applicant is Seragen Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K833931. 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 NITROGEN-UV?

UREA NITROGEN-UV is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Seragen Diagnostics, Inc.. The 510(k) number is K833931.

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

UREA NITROGEN-UV received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833931.

Who is the listed applicant for UREA NITROGEN-UV?

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

What is the FDA product code for UREA NITROGEN-UV?

The FDA product code for UREA NITROGEN-UV is CDQ.

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Related Devices (Code: CDQ)

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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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