CHOLESTEROL PROCEDURE, TEKPOINT TOTAL— 510(k) K770457

Substantially Equivalent

Icn Pharmaceuticals, Inc.

FDA 510(k) clearance K770457 for CHOLESTEROL PROCEDURE, TEKPOINT TOTAL, Substantially Equivalent on 1977-05-03. Applicant: Icn Pharmaceuticals, Inc.. Device class: 1.

Clearance details

Applicant
Icn Pharmaceuticals, Inc.
Product code
Code CGO
Device class
Class 1
Regulation
21 CFR 862.1175
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Orangeburg, NY, US
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