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FDA 510(k)

HDL CHOLESTEROL TEST

K-Number: K885265 · 1989-02-10

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-02-10
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-02-10 under 510(k) number K885265. 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 TEST?

HDL CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1989-02-10. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K885265.

When did HDL CHOLESTEROL TEST receive FDA 510(k) clearance?

HDL CHOLESTEROL TEST received FDA 510(k) clearance on 1989-02-10, under 510(k) number K885265.

Who is the listed applicant for HDL CHOLESTEROL TEST?

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

What is the FDA product code for HDL CHOLESTEROL TEST?

The FDA product code for HDL CHOLESTEROL TEST is LBR.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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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