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FDA 510(k)

BUN RATE REAGENT

K-Number: K811193 · 1981-07-10

ApplicantChem-Elec, Inc.
Decision Date1981-07-10
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN RATE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Chem-Elec, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811193. 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 RATE REAGENT?

BUN RATE REAGENT is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Chem-Elec, Inc.. The 510(k) number is K811193.

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

BUN RATE REAGENT received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811193.

Who is the listed applicant for BUN RATE REAGENT?

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

What is the FDA product code for BUN RATE REAGENT?

The FDA product code for BUN RATE REAGENT is CDS.

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Other records listing Chem-Elec, 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.

K943503CHEMCARD GLUCOSE TESTK864159SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOODK811381ASTRAK811406CREATININE RATE REAGENT KITK811165GLUCOSE OXIDASE RATE REAGENTK811319CHLORIDE REAGENT KIT

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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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