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FDA 510(k)

BUN-REATIVE

K-Number: K760430 · 1976-11-01

ApplicantBoehringer Mannheim Corp.
Decision Date1976-11-01
Product CodeCDS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN-REATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1976-11-01 under 510(k) number K760430. 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-REATIVE?

BUN-REATIVE is a medical device that received FDA 510(k) clearance on 1976-11-01. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K760430.

When did BUN-REATIVE receive FDA 510(k) clearance?

BUN-REATIVE received FDA 510(k) clearance on 1976-11-01, under 510(k) number K760430.

Who is the listed applicant for BUN-REATIVE?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BUN-REATIVE?

The FDA product code for BUN-REATIVE is CDS.

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Other records listing Boehringer Mannheim Corp. 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.

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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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