IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM— 510(k) K061392

Name: FDA 510(k) clearance K061392
Creator: U.S. Food and Drug Administration
Published: 2006-08-01

Substantially Equivalent

Ikonisys, Inc.

FDA 510(k) clearance K061392 for IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM, Substantially Equivalent on 2006-08-01. Applicant: Ikonisys, Inc.. Device class: 2.

Clearance details

Applicant: Ikonisys, Inc.
Product code: Code JOY
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 2006-05-19
Decision date: 2006-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Haven, CT, US

Download summary PDF View on FDA.gov ↗

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