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FDA 510(k)

LIQUID STABLE CHOLESTEROL REAGENT KIT

K-Number: K902678 · 1990-09-25

ApplicantTrace Scientific , Ltd.
Decision Date1990-09-25
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID STABLE CHOLESTEROL REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1990-09-25 under 510(k) number K902678. 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 LIQUID STABLE CHOLESTEROL REAGENT KIT?

LIQUID STABLE CHOLESTEROL REAGENT KIT is a medical device that received FDA 510(k) clearance on 1990-09-25. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K902678.

When did LIQUID STABLE CHOLESTEROL REAGENT KIT receive FDA 510(k) clearance?

LIQUID STABLE CHOLESTEROL REAGENT KIT received FDA 510(k) clearance on 1990-09-25, under 510(k) number K902678.

Who is the listed applicant for LIQUID STABLE CHOLESTEROL REAGENT KIT?

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

What is the FDA product code for LIQUID STABLE CHOLESTEROL REAGENT KIT?

The FDA product code for LIQUID STABLE CHOLESTEROL REAGENT KIT is CHH.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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