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FDA 510(k)

HDL CHOLESTEROL AQUEOUS STANDARDS

K-Number: K840220 · 1984-03-23

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

Device Summary

HDL CHOLESTEROL AQUEOUS STANDARDS 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 K840220. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL CHOLESTEROL AQUEOUS STANDARDS?

HDL CHOLESTEROL AQUEOUS STANDARDS 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 K840220.

When did HDL CHOLESTEROL AQUEOUS STANDARDS receive FDA 510(k) clearance?

HDL CHOLESTEROL AQUEOUS STANDARDS received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840220.

Who is the listed applicant for HDL CHOLESTEROL AQUEOUS STANDARDS?

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 HDL CHOLESTEROL AQUEOUS STANDARDS?

The FDA product code for HDL CHOLESTEROL AQUEOUS STANDARDS is JIS.

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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 PACKK840219TRIGLYCERIDE/CHOLESTEROL AQUEOUSK840278HDL CHOLESTEROL CONTROLS-LEVELSK840189TOTAL CHOLESTEROL REAGENT SET

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Related Devices (Code: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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