KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST— 510(k) K912499

Name: FDA 510(k) clearance K912499
Creator: U.S. Food and Drug Administration
Published: 1991-09-27

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K912499 for KING DIAGNOSTICS CHOLESTEROL REAGENT STRIP TEST, Substantially Equivalent on 1991-09-27. Applicant: King Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1991-06-05
Decision date: 1991-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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