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FDA 510(k)

U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST

K-Number: K864081 · 1986-12-04

ApplicantU. S. Diagnostics, Inc.
Decision Date1986-12-04
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-12-04 under 510(k) number K864081. 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 U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST?

U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1986-12-04. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K864081.

When did U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST receive FDA 510(k) clearance?

U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST received FDA 510(k) clearance on 1986-12-04, under 510(k) number K864081.

Who is the listed applicant for U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST?

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

What is the FDA product code for U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST?

The FDA product code for U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST is CHH.

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Other records listing U. S. Diagnostics, Inc. as applicant

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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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