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FDA 510(k)

CHOLESTEROL-ENZYMATIC REAGENT SET

K-Number: K831863 · 1983-07-22

ApplicantStanbio Laboratory
Decision Date1983-07-22
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL-ENZYMATIC REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1983-07-22 under 510(k) number K831863. 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 REAGENT SET?

CHOLESTEROL-ENZYMATIC REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-07-22. The listed applicant is Stanbio Laboratory. The 510(k) number is K831863.

When did CHOLESTEROL-ENZYMATIC REAGENT SET receive FDA 510(k) clearance?

CHOLESTEROL-ENZYMATIC REAGENT SET received FDA 510(k) clearance on 1983-07-22, under 510(k) number K831863.

Who is the listed applicant for CHOLESTEROL-ENZYMATIC REAGENT SET?

The FDA 510(k) record lists Stanbio Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEROL-ENZYMATIC REAGENT SET?

The FDA product code for CHOLESTEROL-ENZYMATIC REAGENT SET is CHH.

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Other records listing Stanbio Laboratory as applicant

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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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