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FDA 510(k)

DIMENSION WHOLE BLOOD CHOLESTEROL

K-Number: K880723 · 1988-11-08

ApplicantTechnimed, Inc.
Decision Date1988-11-08
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION WHOLE BLOOD CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Technimed, Inc.. It received FDA 510(k) clearance on 1988-11-08 under 510(k) number K880723. 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 DIMENSION WHOLE BLOOD CHOLESTEROL?

DIMENSION WHOLE BLOOD CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1988-11-08. The listed applicant is Technimed, Inc.. The 510(k) number is K880723.

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

DIMENSION WHOLE BLOOD CHOLESTEROL received FDA 510(k) clearance on 1988-11-08, under 510(k) number K880723.

Who is the listed applicant for DIMENSION WHOLE BLOOD CHOLESTEROL?

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

What is the FDA product code for DIMENSION WHOLE BLOOD CHOLESTEROL?

The FDA product code for DIMENSION WHOLE BLOOD CHOLESTEROL is CHH.

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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

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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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