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FDA 510(k)

ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM

K-Number: K903733 · 1991-01-15

ApplicantInstitute For Clinical Applications
Decision Date1991-01-15
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Institute For Clinical Applications. It received FDA 510(k) clearance on 1991-01-15 under 510(k) number K903733. 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 ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM?

ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1991-01-15. The listed applicant is Institute For Clinical Applications. The 510(k) number is K903733.

When did ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM receive FDA 510(k) clearance?

ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM received FDA 510(k) clearance on 1991-01-15, under 510(k) number K903733.

Who is the listed applicant for ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM?

The FDA 510(k) record lists Institute For Clinical Applications as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM?

The FDA product code for ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM is LBR.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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