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FDA 510(k)

COULTER UREA NITROGEN REAGENT

K-Number: K902175 · 1990-06-12

ApplicantCoulter Corp.
Decision Date1990-06-12
Product CodeCDQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER UREA NITROGEN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1990-06-12 under 510(k) number K902175. 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 COULTER UREA NITROGEN REAGENT?

COULTER UREA NITROGEN REAGENT is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Coulter Corp.. The 510(k) number is K902175.

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

COULTER UREA NITROGEN REAGENT received FDA 510(k) clearance on 1990-06-12, under 510(k) number K902175.

Who is the listed applicant for COULTER UREA NITROGEN REAGENT?

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

What is the FDA product code for COULTER UREA NITROGEN REAGENT?

The FDA product code for COULTER UREA NITROGEN REAGENT is CDQ.

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Other records listing Coulter 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.

K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSESK991070COULTER Z2 ANALYZERK990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSK990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAK990352COULTER AC T DIFF 2 ANALYZERK984216IMMUNO-TROL CONTROL CELLS

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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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