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FDA 510(k)

ULTRACHEM E-CHOL, ITEM #65025

K-Number: K813039 · 1981-11-10

ApplicantHarleco
Decision Date1981-11-10
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM E-CHOL, ITEM #65025 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-11-10 under 510(k) number K813039. 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 ULTRACHEM E-CHOL, ITEM #65025?

ULTRACHEM E-CHOL, ITEM #65025 is a medical device that received FDA 510(k) clearance on 1981-11-10. The listed applicant is Harleco. The 510(k) number is K813039.

When did ULTRACHEM E-CHOL, ITEM #65025 receive FDA 510(k) clearance?

ULTRACHEM E-CHOL, ITEM #65025 received FDA 510(k) clearance on 1981-11-10, under 510(k) number K813039.

Who is the listed applicant for ULTRACHEM E-CHOL, ITEM #65025?

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

What is the FDA product code for ULTRACHEM E-CHOL, ITEM #65025?

The FDA product code for ULTRACHEM E-CHOL, ITEM #65025 is CHH.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813044ULTRACHEM ALB, ITEM #64970K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032

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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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