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FDA 510(k)

SYNERMED HDL CHOLESTLEROL REAGENT KIT

K-Number: K924427 · 1992-11-09

ApplicantSynermed, Inc.
Decision Date1992-11-09
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNERMED HDL CHOLESTLEROL REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Synermed, Inc.. It received FDA 510(k) clearance on 1992-11-09 under 510(k) number K924427. 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 SYNERMED HDL CHOLESTLEROL REAGENT KIT?

SYNERMED HDL CHOLESTLEROL REAGENT KIT is a medical device that received FDA 510(k) clearance on 1992-11-09. The listed applicant is Synermed, Inc.. The 510(k) number is K924427.

When did SYNERMED HDL CHOLESTLEROL REAGENT KIT receive FDA 510(k) clearance?

SYNERMED HDL CHOLESTLEROL REAGENT KIT received FDA 510(k) clearance on 1992-11-09, under 510(k) number K924427.

Who is the listed applicant for SYNERMED HDL CHOLESTLEROL REAGENT KIT?

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

What is the FDA product code for SYNERMED HDL CHOLESTLEROL REAGENT KIT?

The FDA product code for SYNERMED HDL CHOLESTLEROL REAGENT KIT is LBR.

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Other records listing Synermed, 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.

K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITK972716SYNERMED TOTAL BILIRUBIN REAGENT KITK971491SYNERMED IR 200 CHEMISTRY ANALYZERK962479SYNERMED ISE REAGENTSK963939SYNERMED DIRECT BILIRUBIN REAGENT KITK960793SYNERMED ENZYMATIC CO2 REAGENT KIT

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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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