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FDA 510(k)

COULTER HDL - CHOLESTEROL REAGENT

K-Number: K902174 · 1990-07-31

ApplicantCoulter Corp.
Decision Date1990-07-31
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER HDL - CHOLESTEROL 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 1990-07-31 under 510(k) number K902174. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER HDL - CHOLESTEROL REAGENT?

COULTER HDL - CHOLESTEROL REAGENT is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Coulter Corp.. The 510(k) number is K902174.

When did COULTER HDL - CHOLESTEROL REAGENT receive FDA 510(k) clearance?

COULTER HDL - CHOLESTEROL REAGENT received FDA 510(k) clearance on 1990-07-31, under 510(k) number K902174.

Who is the listed applicant for COULTER HDL - CHOLESTEROL 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 HDL - CHOLESTEROL REAGENT?

The FDA product code for COULTER HDL - CHOLESTEROL REAGENT is LBR.

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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: LBR)

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.

K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral AtomicsK050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco DiagnosticsK023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERHemagen Diagnostics, Inc.K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan DiagnosticsK992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, 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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