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FDA 510(k)

OLYMPUS UREA NITROGEN (BUN) REAGENT

K-Number: K922597 · 1992-07-10

ApplicantOlympus Corp.
Decision Date1992-07-10
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS UREA NITROGEN (BUN) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1992-07-10 under 510(k) number K922597. 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 OLYMPUS UREA NITROGEN (BUN) REAGENT?

OLYMPUS UREA NITROGEN (BUN) REAGENT is a medical device that received FDA 510(k) clearance on 1992-07-10. The listed applicant is Olympus Corp.. The 510(k) number is K922597.

When did OLYMPUS UREA NITROGEN (BUN) REAGENT receive FDA 510(k) clearance?

OLYMPUS UREA NITROGEN (BUN) REAGENT received FDA 510(k) clearance on 1992-07-10, under 510(k) number K922597.

Who is the listed applicant for OLYMPUS UREA NITROGEN (BUN) REAGENT?

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

What is the FDA product code for OLYMPUS UREA NITROGEN (BUN) REAGENT?

The FDA product code for OLYMPUS UREA NITROGEN (BUN) REAGENT is CDQ.

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Other records listing Olympus 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.

K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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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