FDA 510(k)

N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

K-Number: K971573 · 1997-06-18

Decision Date1997-06-18

Product CodeLBR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 1997-06-18 under 510(k) number K971573. 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 N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET?

N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET is a medical device that received FDA 510(k) clearance on 1997-06-18. The listed applicant is Genzyme Corp.. The 510(k) number is K971573.

When did N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET receive FDA 510(k) clearance?

N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET received FDA 510(k) clearance on 1997-06-18, under 510(k) number K971573.

Who is the listed applicant for N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET?

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

What is the FDA product code for N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET?

The FDA product code for N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET is LBR.

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Related Devices (Code: LBR)

K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral Atomics K050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco Diagnostics K023784RAICHEM 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 Diagnostics K992002AUTOHDL 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.