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FDA 510(k)

VISION WHOLE BLOOD HDL CHOLESTEROL

K-Number: K895158 · 1989-10-02

ApplicantAbbott Laboratories
Decision Date1989-10-02
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VISION WHOLE BLOOD HDL CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-10-02 under 510(k) number K895158. 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 VISION WHOLE BLOOD HDL CHOLESTEROL?

VISION WHOLE BLOOD HDL CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1989-10-02. The listed applicant is Abbott Laboratories. The 510(k) number is K895158.

When did VISION WHOLE BLOOD HDL CHOLESTEROL receive FDA 510(k) clearance?

VISION WHOLE BLOOD HDL CHOLESTEROL received FDA 510(k) clearance on 1989-10-02, under 510(k) number K895158.

Who is the listed applicant for VISION WHOLE BLOOD HDL CHOLESTEROL?

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

What is the FDA product code for VISION WHOLE BLOOD HDL CHOLESTEROL?

The FDA product code for VISION WHOLE BLOOD HDL CHOLESTEROL is CHH.

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Other records listing Abbott Laboratories 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.

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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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