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FDA 510(k)

HDL EX-SEP PRECIPITATING REAGENT

K-Number: K833431 · 1984-01-13

ApplicantPreventive Diagnostics Corp.
Decision Date1984-01-13
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL EX-SEP PRECIPITATING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Preventive Diagnostics Corp.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K833431. 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 EX-SEP PRECIPITATING REAGENT?

HDL EX-SEP PRECIPITATING REAGENT is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Preventive Diagnostics Corp.. The 510(k) number is K833431.

When did HDL EX-SEP PRECIPITATING REAGENT receive FDA 510(k) clearance?

HDL EX-SEP PRECIPITATING REAGENT received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833431.

Who is the listed applicant for HDL EX-SEP PRECIPITATING REAGENT?

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

What is the FDA product code for HDL EX-SEP PRECIPITATING REAGENT?

The FDA product code for HDL EX-SEP PRECIPITATING REAGENT is LBR.

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Other records listing Preventive Diagnostics Corp. 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.

K840677HDL EZ-TZ3 CHOLESTEROL REAGENT KITK840676PDC HDL EZ-SEP CHOLESTEROL REAGENTK840219TRIGLYCERIDE/CHOLESTEROL AQUEOUSK840220HDL CHOLESTEROL AQUEOUS STANDARDSK840278HDL CHOLESTEROL CONTROLS-LEVELSK840968PRESERV TRANSPORT & CULTURE PACK

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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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