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FDA 510(k)

DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS

K-Number: K072523 · 2008-01-22

ApplicantGeneral Atomics
Decision Date2008-01-22
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is General Atomics. It received FDA 510(k) clearance on 2008-01-22 under 510(k) number K072523. 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 DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS?

DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS is a medical device that received FDA 510(k) clearance on 2008-01-22. The listed applicant is General Atomics. The 510(k) number is K072523.

When did DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS receive FDA 510(k) clearance?

DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS received FDA 510(k) clearance on 2008-01-22, under 510(k) number K072523.

Who is the listed applicant for DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS?

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

What is the FDA product code for DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS?

The FDA product code for DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS is LBR.

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Other records listing General Atomics 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.

K082488DIAZYME LP(A) ASSAYK072977DIAZYME APOLIPOPROTEIN A-1 ASSAYK050178HBA1C ENZYMATIC ASSAYK042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITK033360DIAZYME LITHIUM ENZYMATIC ASSAY KIT

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.

K050823DIRECT 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.,K991789ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan Holdings, 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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