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FDA 510(k)

Cholesterol2

K-Number: K203597 · 2022-06-30

ApplicantAbbott Ireland Diagnostics Division
Decision Date2022-06-30
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Cholesterol2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland Diagnostics Division. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K203597. 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 Cholesterol2?

Cholesterol2 is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Abbott Ireland Diagnostics Division. The 510(k) number is K203597.

When did Cholesterol2 receive FDA 510(k) clearance?

Cholesterol2 received FDA 510(k) clearance on 2022-06-30, under 510(k) number K203597.

Who is the listed applicant for Cholesterol2?

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

What is the FDA product code for Cholesterol2?

The FDA product code for Cholesterol2 is CHH.

Other records listing Abbott Ireland Diagnostics Division 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.

K223317Alkaline Phosphatase2K223324Total Bilirubin2K203771Urea Nitrogen2K210633Amylase2K210452Creatinine2K203530Albumin BCP2

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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.AK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro 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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