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FDA 510(k)

CHOLESTEROL PROCEDURE, TEKPOINT TOTAL

K-Number: K770457 · 1977-05-03

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-05-03
Product CodeCGO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL PROCEDURE, TEKPOINT TOTAL is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-05-03 under 510(k) number K770457. 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 PROCEDURE, TEKPOINT TOTAL?

CHOLESTEROL PROCEDURE, TEKPOINT TOTAL is a medical device that received FDA 510(k) clearance on 1977-05-03. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770457.

When did CHOLESTEROL PROCEDURE, TEKPOINT TOTAL receive FDA 510(k) clearance?

CHOLESTEROL PROCEDURE, TEKPOINT TOTAL received FDA 510(k) clearance on 1977-05-03, under 510(k) number K770457.

Who is the listed applicant for CHOLESTEROL PROCEDURE, TEKPOINT TOTAL?

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

What is the FDA product code for CHOLESTEROL PROCEDURE, TEKPOINT TOTAL?

The FDA product code for CHOLESTEROL PROCEDURE, TEKPOINT TOTAL is CGO.

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Related Devices (Code: CGO)

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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., LLCK780545SR-PLUS DIRECT CHOLESTEROL TESTStanbio Laboratory

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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