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FDA 510(k)

BUN-300/BUN-500 UREA NITROGEN REAGENT

K-Number: K934533 · 1993-11-26

ApplicantHorizon Diagnostics, Inc.
Decision Date1993-11-26
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BUN-300/BUN-500 UREA NITROGEN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-11-26 under 510(k) number K934533. The device is classified under product code CDQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUN-300/BUN-500 UREA NITROGEN REAGENT?

BUN-300/BUN-500 UREA NITROGEN REAGENT is a medical device that received FDA 510(k) clearance on 1993-11-26. The listed applicant is Horizon Diagnostics, Inc.. The 510(k) number is K934533.

When did BUN-300/BUN-500 UREA NITROGEN REAGENT receive FDA 510(k) clearance?

BUN-300/BUN-500 UREA NITROGEN REAGENT received FDA 510(k) clearance on 1993-11-26, under 510(k) number K934533.

Who is the listed applicant for BUN-300/BUN-500 UREA NITROGEN REAGENT?

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

What is the FDA product code for BUN-300/BUN-500 UREA NITROGEN REAGENT?

The FDA product code for BUN-300/BUN-500 UREA NITROGEN REAGENT is CDQ.

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Other records listing Horizon Diagnostics, 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.

K971566CREATINE KINASE-MB REAGENT SETK933722HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENTK935712IRON/TIBC REAGENTK930678AMYLASEK930679DIRECT BILIRUBINK930074IN-VITRO DIAGNOSTIC REAGENT SET

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Related Devices (Code: CDQ)

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.

K203771Urea Nitrogen2Abbott Ireland Diagnostics DivisionK110675EASYRA UREA NITROGEN AND CREATININE REAGENTSMedica Corp.K073295UREA/BUN, SCAL, NORTROL, ABTROLThermofisher Scientific OYK070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPHoriba AbxK060120TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEMTeco DiagnosticsK041051RAICHEM BUN RATE REAGENT (LIQUID)Hemagen Diagnostics, 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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