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FDA 510(k)

BLOOD UREA NITROGEN (BUN) REAGENT

K-Number: K771312 · 1977-08-03

ApplicantMallinckrodt Critical Care
Decision Date1977-08-03
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD UREA NITROGEN (BUN) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K771312. 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 (BUN) REAGENT?

BLOOD UREA NITROGEN (BUN) REAGENT is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K771312.

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

BLOOD UREA NITROGEN (BUN) REAGENT received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771312.

Who is the listed applicant for BLOOD UREA NITROGEN (BUN) REAGENT?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLOOD UREA NITROGEN (BUN) REAGENT?

The FDA product code for BLOOD UREA NITROGEN (BUN) REAGENT is CDW.

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Other records listing Mallinckrodt Critical Care as applicant

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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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