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FDA 510(k)

HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173

K-Number: K905284 · 1990-12-11

ApplicantAmresco, Inc.
Decision Date1990-12-11
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 is the device name listed in this FDA 510(k) record. The listed applicant is Amresco, Inc.. It received FDA 510(k) clearance on 1990-12-11 under 510(k) number K905284. 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 HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173?

HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 is a medical device that received FDA 510(k) clearance on 1990-12-11. The listed applicant is Amresco, Inc.. The 510(k) number is K905284.

When did HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 receive FDA 510(k) clearance?

HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 received FDA 510(k) clearance on 1990-12-11, under 510(k) number K905284.

Who is the listed applicant for HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173?

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

What is the FDA product code for HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173?

The FDA product code for HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 is LBR.

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Other records listing Amresco, 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.

K905618GGT REAGENTK904468DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176K905684ALKALINE PHOSPHATASEK905544MAGNESIUM REAGENTK904004AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116K905096GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138

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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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