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FDA 510(k)

CHOLESTEROL DET. IN SERUM

K-Number: K781611 · 1978-10-24

ApplicantFisher Scientific Co., LLC
Decision Date1978-10-24
Product CodeCGO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL DET. IN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781611. 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 DET. IN SERUM?

CHOLESTEROL DET. IN SERUM is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K781611.

When did CHOLESTEROL DET. IN SERUM receive FDA 510(k) clearance?

CHOLESTEROL DET. IN SERUM received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781611.

Who is the listed applicant for CHOLESTEROL DET. IN SERUM?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEROL DET. IN SERUM?

The FDA product code for CHOLESTEROL DET. IN SERUM is CGO.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS 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.K811747KING DIAGNOSTICS CHOLESTEROL TESTKing Diagnostics, Inc.K810090CHOLESTEROL REAGENTAnco Medical Reagents & Assoc.K800682REAGENTS FOR DETERM. CHOLESTEROL/SERUMDiagnostic Solutions, Inc.K780545SR-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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