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FDA 510(k)

TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN

K-Number: K962723 · 1997-03-13

ApplicantTrace America, Inc.
Decision Date1997-03-13
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN is the device name listed in this FDA 510(k) record. The listed applicant is Trace America, Inc.. It received FDA 510(k) clearance on 1997-03-13 under 510(k) number K962723. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN?

TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN is a medical device that received FDA 510(k) clearance on 1997-03-13. The listed applicant is Trace America, Inc.. The 510(k) number is K962723.

When did TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN receive FDA 510(k) clearance?

TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN received FDA 510(k) clearance on 1997-03-13, under 510(k) number K962723.

Who is the listed applicant for TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN?

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

What is the FDA product code for TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN?

The FDA product code for TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN is LBR.

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Other records listing Trace America, 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.

K003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901K980026GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980030AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K973869TRACE REAGENT LINE FOR THE COBAS MIRAK974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

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Related Devices (Code: LBR)

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.

K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral AtomicsK050823DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATORTeco DiagnosticsK023784RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZERHemagen Diagnostics, Inc.K012593VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2Ortho-Clinical Diagnostics, Inc.K992029ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITSElan DiagnosticsK992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, 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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