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FDA 510(k)

SR-PLUS DIRECT CHOLESTEROL TEST

K-Number: K780545 · 1978-05-26

ApplicantStanbio Laboratory
Decision Date1978-05-26
Product CodeCGO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SR-PLUS DIRECT CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1978-05-26 under 510(k) number K780545. 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 SR-PLUS DIRECT CHOLESTEROL TEST?

SR-PLUS DIRECT CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1978-05-26. The listed applicant is Stanbio Laboratory. The 510(k) number is K780545.

When did SR-PLUS DIRECT CHOLESTEROL TEST receive FDA 510(k) clearance?

SR-PLUS DIRECT CHOLESTEROL TEST received FDA 510(k) clearance on 1978-05-26, under 510(k) number K780545.

Who is the listed applicant for SR-PLUS DIRECT CHOLESTEROL TEST?

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 SR-PLUS DIRECT CHOLESTEROL TEST?

The FDA product code for SR-PLUS DIRECT CHOLESTEROL TEST is CGO.

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Other records listing Stanbio Laboratory as applicant

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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.

K850938CHOLESTEROLDilab, Inc.K811747KING DIAGNOSTICS CHOLESTEROL TESTKing Diagnostics, Inc.K810090CHOLESTEROL REAGENTAnco Medical Reagents & Assoc.K800682REAGENTS FOR DETERM. CHOLESTEROL/SERUMDiagnostic Solutions, Inc.K781611CHOLESTEROL DET. IN SERUMFisher Scientific Co., LLCK772043ALPHA/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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