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FDA 510(k)

CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES

K-Number: K882488 · 1988-08-15

ApplicantCanyon Diagnostics, Inc.
Decision Date1988-08-15
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Canyon Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-08-15 under 510(k) number K882488. 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 CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES?

CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES is a medical device that received FDA 510(k) clearance on 1988-08-15. The listed applicant is Canyon Diagnostics, Inc.. The 510(k) number is K882488.

When did CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES receive FDA 510(k) clearance?

CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES received FDA 510(k) clearance on 1988-08-15, under 510(k) number K882488.

Who is the listed applicant for CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES?

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

What is the FDA product code for CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES?

The FDA product code for CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES is LBR.

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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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