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FDA 510(k)

BLOOD UREA NITROGEN

K-Number: K874532 · 1988-01-05

ApplicantCatachem, Inc.
Decision Date1988-01-05
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD UREA NITROGEN is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K874532. 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 BLOOD UREA NITROGEN?

BLOOD UREA NITROGEN is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Catachem, Inc.. The 510(k) number is K874532.

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

BLOOD UREA NITROGEN received FDA 510(k) clearance on 1988-01-05, under 510(k) number K874532.

Who is the listed applicant for BLOOD UREA NITROGEN?

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

What is the FDA product code for BLOOD UREA NITROGEN?

The FDA product code for BLOOD UREA NITROGEN is CDW.

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Other records listing Catachem, 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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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.

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.K844156UREA NITROGEN REAGENT SETLivonia Diagnostics, 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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