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FDA 510(k)

UREA NITROGEN

K-Number: K781305 · 1978-08-31

ApplicantAnalytical & Research Chemicals, Inc.
Decision Date1978-08-31
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UREA NITROGEN is the device name listed in this FDA 510(k) record. The listed applicant is Analytical & Research Chemicals, Inc.. It received FDA 510(k) clearance on 1978-08-31 under 510(k) number K781305. The device is classified under product code CDW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA NITROGEN?

UREA NITROGEN is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Analytical & Research Chemicals, Inc.. The 510(k) number is K781305.

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

UREA NITROGEN received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781305.

Who is the listed applicant for UREA NITROGEN?

The FDA 510(k) record lists Analytical & Research Chemicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UREA NITROGEN?

The FDA product code for UREA NITROGEN is CDW.

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.

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Other records listing Analytical & Research Chemicals, 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.

K823784ENZYMATIC CHOLESTEROL (COLORIMETRICK823786ALKALINE PHOSPHATASEK823806DIRECT CREATININE PROCEDUREK781441BCG ALBUMIN REAGETK781460CHLORIDE REAGENTK781324ALP TEST

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Related Devices (Code: CDW)

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.

K874532BLOOD UREA NITROGENCatachem, Inc.K871320FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814American Research Products Co.K863425AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346American Research Products Co.K861775TWIN BUN/GLUCOSEBoehringer Mannheim Corp.K860419UREA NITROGEN REAGENT SETSterling Diagnostics, Inc.K850937UREADilab, Inc.

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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