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FDA 510(k)

ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS

K-Number: K960378 · 1996-04-03

ApplicantActimed Laboratories, Inc.
Decision Date1996-04-03
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS 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 1996-04-03 under 510(k) number K960378. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS?

ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS is a medical device that received FDA 510(k) clearance on 1996-04-03. The listed applicant is Actimed Laboratories, Inc.. The 510(k) number is K960378.

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

ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS received FDA 510(k) clearance on 1996-04-03, under 510(k) number K960378.

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

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 ASSAYED TOTAL CHOLESTEROL CONTROLS?

The FDA product code for ENA-C-T ASSAYED TOTAL CHOLESTEROL CONTROLS is JJX.

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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)K960377ENA-C-T TOTAL CHOLESTEROL TEST

Related Devices (Code: JJX)

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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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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