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FDA 510(k)

ENZYMATIC CHOLESTEROL KIT

K-Number: K843222 · 1984-09-28

ApplicantLivonia Diagnostics, Inc.
Decision Date1984-09-28
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CHOLESTEROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Livonia Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-09-28 under 510(k) number K843222. 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 CHOLESTEROL KIT?

ENZYMATIC CHOLESTEROL KIT is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is Livonia Diagnostics, Inc.. The 510(k) number is K843222.

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

ENZYMATIC CHOLESTEROL KIT received FDA 510(k) clearance on 1984-09-28, under 510(k) number K843222.

Who is the listed applicant for ENZYMATIC CHOLESTEROL KIT?

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

What is the FDA product code for ENZYMATIC CHOLESTEROL KIT?

The FDA product code for ENZYMATIC CHOLESTEROL KIT is CHH.

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Other records listing Livonia Diagnostics, 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.

K852161SERUM IRON/VIBC REAGENT SETK844322SGOT REAGENT SETK844283SGPT REAGENT SETK844237ALKALINE PHOSPHATASE REAGENT SETK844156UREA NITROGEN REAGENT SETK844182INORGANIC PHOSPHORUS REAGENT SET

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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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