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FDA 510(k)

BUN KIT

K-Number: K800590 · 1980-04-04

ApplicantNobel Scientific Industries, Inc.
Decision Date1980-04-04
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Scientific Industries, Inc.. It received FDA 510(k) clearance on 1980-04-04 under 510(k) number K800590. 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 KIT?

BUN KIT is a medical device that received FDA 510(k) clearance on 1980-04-04. The listed applicant is Nobel Scientific Industries, Inc.. The 510(k) number is K800590.

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

BUN KIT received FDA 510(k) clearance on 1980-04-04, under 510(k) number K800590.

Who is the listed applicant for BUN KIT?

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

What is the FDA product code for BUN KIT?

The FDA product code for BUN KIT is CDS.

Other records listing Nobel Scientific Industries, Inc. as applicant

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K854717NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928K854716NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909K854718NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926K850944NSI LYSING-D REAGENT -4000 MLK844782NSI ELT-D DILUTING FLUID 4000MLK823283FLUSHING SOLUTION

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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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