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FDA 510(k)

IL TEST(TM) HDL CHOLESTEROL

K-Number: K914811 · 1992-01-09

ApplicantInstrumentation Laboratory CO
Decision Date1992-01-09
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL TEST(TM) HDL CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1992-01-09 under 510(k) number K914811. 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 IL TEST(TM) HDL CHOLESTEROL?

IL TEST(TM) HDL CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1992-01-09. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K914811.

When did IL TEST(TM) HDL CHOLESTEROL receive FDA 510(k) clearance?

IL TEST(TM) HDL CHOLESTEROL received FDA 510(k) clearance on 1992-01-09, under 510(k) number K914811.

Who is the listed applicant for IL TEST(TM) HDL CHOLESTEROL?

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

What is the FDA product code for IL TEST(TM) HDL CHOLESTEROL?

The FDA product code for IL TEST(TM) HDL CHOLESTEROL 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

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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