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FDA 510(k)

SERUM, BLOOD UREA NITIOGEN

K-Number: K781885 · 1978-12-20

ApplicantFisher Scientific Co., LLC
Decision Date1978-12-20
Product CodeCDW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM, BLOOD UREA NITIOGEN is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781885. 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 SERUM, BLOOD UREA NITIOGEN?

SERUM, BLOOD UREA NITIOGEN is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K781885.

When did SERUM, BLOOD UREA NITIOGEN receive FDA 510(k) clearance?

SERUM, BLOOD UREA NITIOGEN received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781885.

Who is the listed applicant for SERUM, BLOOD UREA NITIOGEN?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERUM, BLOOD UREA NITIOGEN?

The FDA product code for SERUM, BLOOD UREA NITIOGEN is CDW.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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