INNOVACON SPECTRUM II TEST CARD— 510(k) K061718

Name: FDA 510(k) clearance K061718
Creator: U.S. Food and Drug Administration
Published: 2006-11-13

Substantially Equivalent

Innovacon, Inc.

FDA 510(k) clearance K061718 for INNOVACON SPECTRUM II TEST CARD, Substantially Equivalent on 2006-11-13. Applicant: Innovacon, Inc.. Device class: 2.

Clearance details

Applicant: Innovacon, Inc.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2006-06-19
Decision date: 2006-11-13
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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