IRON/TIBC REAGENT— 510(k) K935712

Substantially Equivalent

Horizon Diagnostics, Inc.

FDA 510(k) clearance K935712 for IRON/TIBC REAGENT, Substantially Equivalent on 1995-09-20. Applicant: Horizon Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Horizon Diagnostics, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1993-11-30
Decision date: 1995-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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