Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Device Classification Under Section 513(f)(2)(De Novo)
FDA Home
Medical Devices
Databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
Back to Search Results
Device Classification Name
early growth response gene 1 (egr1) fish probe kit for specimen characterization
De Novo Number
DEN130010
510(K) Number
K123951
Device Name
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
Requester
abbott molecular, inc.
1300 east touhy avenue
des plaines, IL 60018
Contact
nancy w bengtson
Regulation Number
864.1870
Classification Product Code
PDO
Date Received
04/09/2013
Decision Date
07/29/2013
Decision
granted (DENG)
Classification Advisory Committee
Hematology
Review Advisory Committee
Pathology
Reclassification Order
Reclassification Order
FDA Review
Decision Summary
Type
Post-NSE
-
-