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FDA 510(k)

HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)

K-Number: K931773 · 1993-08-16

ApplicantKing Diagnostics, Inc.
Decision Date1993-08-16
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1993-08-16 under 510(k) number K931773. 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 PRECIPITATING REAGENT (DEXTRAN SULFATE)?

HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) is a medical device that received FDA 510(k) clearance on 1993-08-16. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K931773.

When did HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) receive FDA 510(k) clearance?

HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) received FDA 510(k) clearance on 1993-08-16, under 510(k) number K931773.

Who is the listed applicant for HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)?

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

What is the FDA product code for HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)?

The FDA product code for HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) is LBR.

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Other records listing King Diagnostics, 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.

K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931834KING SODIUM/POTASSIUM STANDARD MODIFIEDK931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENTK922921KING DIAGNOSTICS CHLORIDE REAGENT

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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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