IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM— 510(k) K935287

Name: FDA 510(k) clearance K935287
Creator: U.S. Food and Drug Administration
Published: 1994-01-03

Substantially Equivalent

Miles, Inc.

FDA 510(k) clearance K935287 for IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM, Substantially Equivalent on 1994-01-03. Applicant: Miles, Inc.. Device class: 1.

Clearance details

Applicant: Miles, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1993-11-03
Decision date: 1994-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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