DIRECT TIBC CALIBRATOR— 510(k) K000783

Name: FDA 510(k) clearance K000783
Creator: U.S. Food and Drug Administration
Published: 2000-05-04

Substantially Equivalent

Reference Diagnostics, Inc.

FDA 510(k) clearance K000783 for DIRECT TIBC CALIBRATOR, Substantially Equivalent on 2000-05-04. Applicant: Reference Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Reference Diagnostics, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2000-03-10
Decision date: 2000-05-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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