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FDA 510(k)

CHOLESTEROL ENZYMATIC ENDPOINT

K-Number: K923504 · 1994-01-10

ApplicantRandox Laboratories, Ltd.
Decision Date1994-01-10
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL ENZYMATIC ENDPOINT is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 1994-01-10 under 510(k) number K923504. 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 CHOLESTEROL ENZYMATIC ENDPOINT?

CHOLESTEROL ENZYMATIC ENDPOINT is a medical device that received FDA 510(k) clearance on 1994-01-10. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K923504.

When did CHOLESTEROL ENZYMATIC ENDPOINT receive FDA 510(k) clearance?

CHOLESTEROL ENZYMATIC ENDPOINT received FDA 510(k) clearance on 1994-01-10, under 510(k) number K923504.

Who is the listed applicant for CHOLESTEROL ENZYMATIC ENDPOINT?

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

What is the FDA product code for CHOLESTEROL ENZYMATIC ENDPOINT?

The FDA product code for CHOLESTEROL ENZYMATIC ENDPOINT is CHH.

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Other records listing Randox Laboratories, 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.

K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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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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