TERUMO SENSIBEAD(TM) EIA HLH KIT— 510(k) K863929

Name: FDA 510(k) clearance K863929
Creator: U.S. Food and Drug Administration
Published: 1986-11-13

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K863929 for TERUMO SENSIBEAD(TM) EIA HLH KIT, Substantially Equivalent on 1986-11-13. Applicant: Terumo Medical Corp.. Device class: 1.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1986-10-08
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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