VYSIS D7S486/CEP 7 FISH PROBE KIT— 510(k) K131508

Name: FDA 510(k) clearance K131508
Creator: U.S. Food and Drug Administration
Published: 2013-09-13

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K131508 for VYSIS D7S486/CEP 7 FISH PROBE KIT, Substantially Equivalent on 2013-09-13. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code PFG
Device class: Class 2
Regulation: 21 CFR 864.1870
Advisory panel: Hematology
Date received: 2013-05-24
Decision date: 2013-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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