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FDA 510(k)

HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)

K-Number: K932766 · 1993-12-10

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1993-12-10
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1993-12-10 under 510(k) number K932766. 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-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)?

HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) is a medical device that received FDA 510(k) clearance on 1993-12-10. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K932766.

When did HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) receive FDA 510(k) clearance?

HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) received FDA 510(k) clearance on 1993-12-10, under 510(k) number K932766.

Who is the listed applicant for HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)?

The FDA product code for HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) is LBR.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CALK912825MAGNESIUM ASSAY KIT, CAT.# 100-12

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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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