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FDA 510(k)

CHOLESTEROL

K-Number: K850938 · 1985-06-25

ApplicantDilab, Inc.
Decision Date1985-06-25
Product CodeCGO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Dilab, Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K850938. The device is classified under product code CGO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTEROL?

CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Dilab, Inc.. The 510(k) number is K850938.

When did CHOLESTEROL receive FDA 510(k) clearance?

CHOLESTEROL received FDA 510(k) clearance on 1985-06-25, under 510(k) number K850938.

Who is the listed applicant for CHOLESTEROL?

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

What is the FDA product code for CHOLESTEROL?

The FDA product code for CHOLESTEROL is CGO.

Related Clinical Trials

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.

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Other records listing Dilab, 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.

K862530RAPID AS LATEXK850931ALBUMINK850934PHOSPHORUSK850933URIC ACIDK850936TOTAL PROTEINSK850932CREATININE

View all 11 devices →

Related Devices (Code: CGO)

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.

K811747KING DIAGNOSTICS CHOLESTEROL TESTKing Diagnostics, Inc.K810090CHOLESTEROL REAGENTAnco Medical Reagents & Assoc.K800682REAGENTS FOR DETERM. CHOLESTEROL/SERUMDiagnostic Solutions, Inc.K781611CHOLESTEROL DET. IN SERUMFisher Scientific Co., LLCK780545SR-PLUS DIRECT CHOLESTEROL TESTStanbio LaboratoryK772043ALPHA/CHOLStandard Scientific, 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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