DIMENSION WHOLE BLOOD CHOLESTEROL— 510(k) K880723

Name: FDA 510(k) clearance K880723
Creator: U.S. Food and Drug Administration
Published: 1988-11-08

Substantially Equivalent

Technimed, Inc.

FDA 510(k) clearance K880723 for DIMENSION WHOLE BLOOD CHOLESTEROL, Substantially Equivalent on 1988-11-08. Applicant: Technimed, Inc.. Device class: 1.

Clearance details

Applicant: Technimed, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1988-02-23
Decision date: 1988-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

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