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FDA 510(k)

BUN REAGENT KIT

K-Number: K800071 · 1980-02-05

ApplicantFisher Scientific Co., LLC
Decision Date1980-02-05
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN REAGENT KIT 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 1980-02-05 under 510(k) number K800071. The device is classified under product code CDS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUN REAGENT KIT?

BUN REAGENT KIT is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K800071.

When did BUN REAGENT KIT receive FDA 510(k) clearance?

BUN REAGENT KIT received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800071.

Who is the listed applicant for BUN REAGENT KIT?

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 BUN REAGENT KIT?

The FDA product code for BUN REAGENT KIT is CDS.

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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: CDS)

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.

K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestEpocal, Inc.K040973BUN REAGENTGenchem, Inc.K033056BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENTDiamond Diagnostics, Inc.K925550HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806Hichem DiagnosticsK860543BLOOD UREA NITROGEN (BUN) TESTCARDIlex Corp.K855091CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYSSen Tech Medical Corp.

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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