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FDA 510(k)

TRIGLYCERIDE/CHOLESTEROL AQUEOUS

K-Number: K840219 · 1984-03-23

ApplicantPreventive Diagnostics Corp.
Decision Date1984-03-23
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDE/CHOLESTEROL AQUEOUS is the device name listed in this FDA 510(k) record. The listed applicant is Preventive Diagnostics Corp.. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840219. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGLYCERIDE/CHOLESTEROL AQUEOUS?

TRIGLYCERIDE/CHOLESTEROL AQUEOUS is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Preventive Diagnostics Corp.. The 510(k) number is K840219.

When did TRIGLYCERIDE/CHOLESTEROL AQUEOUS receive FDA 510(k) clearance?

TRIGLYCERIDE/CHOLESTEROL AQUEOUS received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840219.

Who is the listed applicant for TRIGLYCERIDE/CHOLESTEROL AQUEOUS?

The FDA 510(k) record lists Preventive Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIGLYCERIDE/CHOLESTEROL AQUEOUS?

The FDA product code for TRIGLYCERIDE/CHOLESTEROL AQUEOUS is JIX.

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Other records listing Preventive Diagnostics Corp. 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.

K840677HDL EZ-TZ3 CHOLESTEROL REAGENT KITK840676PDC HDL EZ-SEP CHOLESTEROL REAGENTK840968PRESERV TRANSPORT & CULTURE PACKK840220HDL CHOLESTEROL AQUEOUS STANDARDSK840278HDL CHOLESTEROL CONTROLS-LEVELSK840189TOTAL CHOLESTEROL REAGENT SET

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Related Devices (Code: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, 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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