VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)— 510(k) DEN130010

Name: FDA 510(k) clearance DEN130010
Creator: U.S. Food and Drug Administration
Published: 2013-07-29

Unknown

Abbott Molecular, Inc.

FDA 510(k) clearance DEN130010 for VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION), Unknown on 2013-07-29. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code PDO
Device class: Class 2
Regulation: 21 CFR 864.1870
Advisory panel: Hematology
Date received: 2013-04-09
Decision date: 2013-07-29
Decision: Unknown
Clearance type: Post-NSE
Location: Des Plaines, IL, US

View on FDA.gov ↗

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