VITALAB IRON REAGENT— 510(k) K033983

Substantially Equivalent

Clinical Data, Inc.

FDA 510(k) clearance K033983 for VITALAB IRON REAGENT, Substantially Equivalent on 2004-05-21. Applicant: Clinical Data, Inc.. Device class: 1.

Clearance details

Applicant: Clinical Data, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 2003-12-23
Decision date: 2004-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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K040631 — VITALAB DIRECT BILIRUBIN REAGENT2004-03-18
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Data sourced from openFDA. This site is unofficial and independent of the FDA.