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FDA 510(k)

HDL PRECIPITANT REAGENT SET

K-Number: K821203 · 1982-07-13

ApplicantOmega Medical Electronics
Decision Date1982-07-13
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL PRECIPITANT REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Omega Medical Electronics. It received FDA 510(k) clearance on 1982-07-13 under 510(k) number K821203. 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 PRECIPITANT REAGENT SET?

HDL PRECIPITANT REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-07-13. The listed applicant is Omega Medical Electronics. The 510(k) number is K821203.

When did HDL PRECIPITANT REAGENT SET receive FDA 510(k) clearance?

HDL PRECIPITANT REAGENT SET received FDA 510(k) clearance on 1982-07-13, under 510(k) number K821203.

Who is the listed applicant for HDL PRECIPITANT REAGENT SET?

The FDA 510(k) record lists Omega Medical Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL PRECIPITANT REAGENT SET?

The FDA product code for HDL PRECIPITANT REAGENT SET is LBR.

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Other records listing Omega Medical Electronics 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.

K823691PHOSPHORUS REAGENT SETK821212UREA NITROGEN REAGENT SETK821206SGPT-UV REAGENT SETK821204GLUCOSE(ENZYMATIC) REAGENT SETK821208SGOT-UV REAGENT SETK821205TRIGLYCERIDE REAGENT SET

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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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