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FDA 510(k)

ENZYMATIC CHOLESTEROL (COLORIMETRIC

K-Number: K823784 · 1983-01-14

ApplicantAnalytical & Research Chemicals, Inc.
Decision Date1983-01-14
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CHOLESTEROL (COLORIMETRIC is the device name listed in this FDA 510(k) record. The listed applicant is Analytical & Research Chemicals, Inc.. It received FDA 510(k) clearance on 1983-01-14 under 510(k) number K823784. 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 (COLORIMETRIC?

ENZYMATIC CHOLESTEROL (COLORIMETRIC is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Analytical & Research Chemicals, Inc.. The 510(k) number is K823784.

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

ENZYMATIC CHOLESTEROL (COLORIMETRIC received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823784.

Who is the listed applicant for ENZYMATIC CHOLESTEROL (COLORIMETRIC?

The FDA 510(k) record lists Analytical & Research Chemicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZYMATIC CHOLESTEROL (COLORIMETRIC?

The FDA product code for ENZYMATIC CHOLESTEROL (COLORIMETRIC is CHH.

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Other records listing Analytical & Research Chemicals, 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.

K823806DIRECT CREATININE PROCEDUREK823786ALKALINE PHOSPHATASEK781441BCG ALBUMIN REAGETK781460CHLORIDE REAGENTK781308GLUCOLOURK781324ALP TEST

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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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