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FDA 510(k)

ENZYMATIC CHOLESTEROL KIT

K-Number: K820951 · 1982-04-26

ApplicantAnco Medical Reagents & Assoc.
Decision Date1982-04-26
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 Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1982-04-26 under 510(k) number K820951. 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 1982-04-26. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K820951.

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

ENZYMATIC CHOLESTEROL KIT received FDA 510(k) clearance on 1982-04-26, under 510(k) number K820951.

Who is the listed applicant for ENZYMATIC CHOLESTEROL KIT?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. 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 Anco Medical Reagents & Assoc. 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.

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTHK831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821658HEMOGLOBIN REAGENTK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820466SGOT 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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