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FDA 510(k)

UREA NITROGEN TEST KIT

K-Number: K781306 · 1978-08-31

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

Device Summary

UREA NITROGEN TEST KIT 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 K781306. The device is classified under product code CDL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UREA NITROGEN TEST KIT?

UREA NITROGEN TEST KIT 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 K781306.

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

UREA NITROGEN TEST KIT received FDA 510(k) clearance on 1978-08-31, under 510(k) number K781306.

Who is the listed applicant for UREA NITROGEN TEST KIT?

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 TEST KIT?

The FDA product code for UREA NITROGEN TEST KIT is CDL.

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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 REAGENTK781305UREA NITROGEN

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Related Devices (Code: CDL)

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.

K896845RAICHEM(TM) UREA NITROGEN (COLOR) REAGENTReagents Applications, Inc.K893128STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010Stanbio LaboratoryK871651COLORIMETRIC BUN REAGENT KITBiochemical Trade, Inc.K864742UREA NITROGEN(BUN), COLORIMETRIC METHODTech-Co, Inc.K863889UREA NITROGEN TESTU. S. Diagnostics, Inc.K863076UREAFASTJ. D. Assoc.

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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