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FDA 510(k)

ENA-C-T TOTAL CHOLESTEROL TEST

K-Number: K960377 · 1996-05-02

ApplicantActimed Laboratories, Inc.
Decision Date1996-05-02
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENA-C-T TOTAL CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Actimed Laboratories, Inc.. It received FDA 510(k) clearance on 1996-05-02 under 510(k) number K960377. 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 ENA-C-T TOTAL CHOLESTEROL TEST?

ENA-C-T TOTAL CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1996-05-02. The listed applicant is Actimed Laboratories, Inc.. The 510(k) number is K960377.

When did ENA-C-T TOTAL CHOLESTEROL TEST receive FDA 510(k) clearance?

ENA-C-T TOTAL CHOLESTEROL TEST received FDA 510(k) clearance on 1996-05-02, under 510(k) number K960377.

Who is the listed applicant for ENA-C-T TOTAL CHOLESTEROL TEST?

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

What is the FDA product code for ENA-C-T TOTAL CHOLESTEROL TEST?

The FDA product code for ENA-C-T TOTAL CHOLESTEROL TEST is CHH.

Related Clinical Trials

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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Other records listing Actimed Laboratories, 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.

K981181ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)K960378ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS

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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