TERUMO SENSIBEAD EIA FSH KIT— 510(k) K863928

Name: FDA 510(k) clearance K863928
Creator: U.S. Food and Drug Administration
Published: 1986-12-04

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K863928 for TERUMO SENSIBEAD EIA FSH KIT, Substantially Equivalent on 1986-12-04. Applicant: Terumo Medical Corp.. Device class: 1.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1986-10-08
Decision date: 1986-12-04
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.