FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY— 510(k) K864882

Name: FDA 510(k) clearance K864882
Creator: U.S. Food and Drug Administration
Published: 1987-01-21

Substantially Equivalent

Pointe Scientific, Inc.,

FDA 510(k) clearance K864882 for FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY, Substantially Equivalent on 1987-01-21. Applicant: Pointe Scientific, Inc.,. Device class: 1.

Clearance details

Applicant: Pointe Scientific, Inc.,
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1986-12-12
Decision date: 1987-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Detroit, MI, US

Download summary PDF View on FDA.gov ↗

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