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FDA 510(k)

KING DIAGNOSTICS CHOLESTEROL TEST

K-Number: K811747 · 1981-07-10

ApplicantKing Diagnostics, Inc.
Decision Date1981-07-10
Product CodeCGO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KING DIAGNOSTICS CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is King Diagnostics, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811747. 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 KING DIAGNOSTICS CHOLESTEROL TEST?

KING DIAGNOSTICS CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is King Diagnostics, Inc.. The 510(k) number is K811747.

When did KING DIAGNOSTICS CHOLESTEROL TEST receive FDA 510(k) clearance?

KING DIAGNOSTICS CHOLESTEROL TEST received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811747.

Who is the listed applicant for KING DIAGNOSTICS CHOLESTEROL TEST?

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

What is the FDA product code for KING DIAGNOSTICS CHOLESTEROL TEST?

The FDA product code for KING DIAGNOSTICS CHOLESTEROL TEST is CGO.

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Other records listing King Diagnostics, 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.

K933329KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENTK931834KING SODIUM/POTASSIUM STANDARD MODIFIEDK931773HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)K931326KING DIAGNOSTICS CK REAGENTK923129KING DIAGNOSTICS GLUCOSE (HK) REAGENTK922969KING DIAGNOSTICS UREA NITROGEN REAGENT

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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.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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