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FDA 510(k)

COULTER CARBON DIOXIDE REAGENT

K-Number: K902229 · 1990-06-12

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

Device Summary

COULTER CARBON DIOXIDE 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 K902229. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER CARBON DIOXIDE REAGENT?

COULTER CARBON DIOXIDE 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 K902229.

When did COULTER CARBON DIOXIDE REAGENT receive FDA 510(k) clearance?

COULTER CARBON DIOXIDE REAGENT received FDA 510(k) clearance on 1990-06-12, under 510(k) number K902229.

Who is the listed applicant for COULTER CARBON DIOXIDE 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 CARBON DIOXIDE REAGENT?

The FDA product code for COULTER CARBON DIOXIDE REAGENT is KHS.

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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

View all 51 devices →

Related Devices (Code: KHS)

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.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

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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