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FDA 510(k)

CHOLESTEROL REAGENT ENZYMATIC

K-Number: K803287 · 1981-01-16

ApplicantRai, Inc.
Decision Date1981-01-16
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL REAGENT ENZYMATIC is the device name listed in this FDA 510(k) record. The listed applicant is Rai, Inc.. It received FDA 510(k) clearance on 1981-01-16 under 510(k) number K803287. 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 CHOLESTEROL REAGENT ENZYMATIC?

CHOLESTEROL REAGENT ENZYMATIC is a medical device that received FDA 510(k) clearance on 1981-01-16. The listed applicant is Rai, Inc.. The 510(k) number is K803287.

When did CHOLESTEROL REAGENT ENZYMATIC receive FDA 510(k) clearance?

CHOLESTEROL REAGENT ENZYMATIC received FDA 510(k) clearance on 1981-01-16, under 510(k) number K803287.

Who is the listed applicant for CHOLESTEROL REAGENT ENZYMATIC?

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

What is the FDA product code for CHOLESTEROL REAGENT ENZYMATIC?

The FDA product code for CHOLESTEROL REAGENT ENZYMATIC is CHH.

Related Clinical Trials

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Other records listing Rai, 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.

K823187CHOLESTEROL HIGH SENSIT. REAGENT ENZYM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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