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FDA 510(k)

ENZYMATIC REAGENT FOR CHOLESTEROL MEAS

K-Number: K781013 · 1978-07-28

ApplicantCoulter Electronics, Inc.
Decision Date1978-07-28
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC REAGENT FOR CHOLESTEROL MEAS is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1978-07-28 under 510(k) number K781013. 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 ENZYMATIC REAGENT FOR CHOLESTEROL MEAS?

ENZYMATIC REAGENT FOR CHOLESTEROL MEAS is a medical device that received FDA 510(k) clearance on 1978-07-28. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K781013.

When did ENZYMATIC REAGENT FOR CHOLESTEROL MEAS receive FDA 510(k) clearance?

ENZYMATIC REAGENT FOR CHOLESTEROL MEAS received FDA 510(k) clearance on 1978-07-28, under 510(k) number K781013.

Who is the listed applicant for ENZYMATIC REAGENT FOR CHOLESTEROL MEAS?

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

What is the FDA product code for ENZYMATIC REAGENT FOR CHOLESTEROL MEAS?

The FDA product code for ENZYMATIC REAGENT FOR CHOLESTEROL MEAS is CHH.

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Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: CHH)

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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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