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FDA 510(k)

HDL REAGENT SET FOR LIPOPROTEINS

K-Number: K780389 · 1978-04-19

ApplicantWorthington Biochemical Corp.
Decision Date1978-04-19
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL REAGENT SET FOR LIPOPROTEINS is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Biochemical Corp.. It received FDA 510(k) clearance on 1978-04-19 under 510(k) number K780389. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL REAGENT SET FOR LIPOPROTEINS?

HDL REAGENT SET FOR LIPOPROTEINS is a medical device that received FDA 510(k) clearance on 1978-04-19. The listed applicant is Worthington Biochemical Corp.. The 510(k) number is K780389.

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

HDL REAGENT SET FOR LIPOPROTEINS received FDA 510(k) clearance on 1978-04-19, under 510(k) number K780389.

Who is the listed applicant for HDL REAGENT SET FOR LIPOPROTEINS?

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

What is the FDA product code for HDL REAGENT SET FOR LIPOPROTEINS?

The FDA product code for HDL REAGENT SET FOR LIPOPROTEINS is CHH.

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Other records listing Worthington Biochemical 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.

K780096LDH ISOENZYME CONTROL SERUMK772356LDH ISOENZYME COLUMN REAGENT SETK772025URIC ACID STD. FOR QUANT. URIC ACIDK771143INORGANIC PHOSPHORUS STANDARDSK770831STATZYME URIC ACID REAGENTK771001STATZYME GLUCOSE

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Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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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