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FDA 510(k)

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR

K-Number: K962186 · 1996-08-19

ApplicantGenzyme Corp.
Decision Date1996-08-19
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 1996-08-19 under 510(k) number K962186. 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 HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR?

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR is a medical device that received FDA 510(k) clearance on 1996-08-19. The listed applicant is Genzyme Corp.. The 510(k) number is K962186.

When did N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR receive FDA 510(k) clearance?

N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR received FDA 510(k) clearance on 1996-08-19, under 510(k) number K962186.

Who is the listed applicant for N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR?

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 HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR?

The FDA product code for N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR is LBR.

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Other records listing Genzyme Corp. 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.

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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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