TERUMO SENSIBEAD EIA COLORIMETER— 510(k) K854210

Name: FDA 510(k) clearance K854210
Creator: U.S. Food and Drug Administration
Published: 1985-12-05

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K854210 for TERUMO SENSIBEAD EIA COLORIMETER, Substantially Equivalent on 1985-12-05. Applicant: Terumo Medical Corp.. Device class: 1.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1985-10-16
Decision date: 1985-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.