ALFERR TIBC TUBE— 510(k) K864548

Substantially Equivalent

Benchmark Reagents

FDA 510(k) clearance K864548 for ALFERR TIBC TUBE, Substantially Equivalent on 1987-02-02. Applicant: Benchmark Reagents. Device class: 1.

Clearance details

Applicant: Benchmark Reagents
Product code: Code JQE
Device class: Class 1
Regulation: 21 CFR 862.1415
Advisory panel: Clinical Chemistry
Date received: 1986-11-19
Decision date: 1987-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.