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FDA 510(k)

HIGH DENSITY LIPOPROTEIN CHOLESTEROL

K-Number: K912823 · 1991-08-16

ApplicantCreative Laboratory Products, Inc.
Decision Date1991-08-16
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HIGH DENSITY LIPOPROTEIN CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Creative Laboratory Products, Inc.. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K912823. 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 HIGH DENSITY LIPOPROTEIN CHOLESTEROL?

HIGH DENSITY LIPOPROTEIN CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Creative Laboratory Products, Inc.. The 510(k) number is K912823.

When did HIGH DENSITY LIPOPROTEIN CHOLESTEROL receive FDA 510(k) clearance?

HIGH DENSITY LIPOPROTEIN CHOLESTEROL received FDA 510(k) clearance on 1991-08-16, under 510(k) number K912823.

Who is the listed applicant for HIGH DENSITY LIPOPROTEIN CHOLESTEROL?

The FDA 510(k) record lists Creative Laboratory Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGH DENSITY LIPOPROTEIN CHOLESTEROL?

The FDA product code for HIGH DENSITY LIPOPROTEIN CHOLESTEROL is LBR.

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Other records listing Creative Laboratory Products, Inc. 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.

K950589CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HLK942284CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SETK922995LIPID CONTROLSK913427SICKLE HEMOGLOBIN (HBA/S) CONTROL SETK913371TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CALK913585LIPASE LINEARITY CONTROL

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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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