VYSIS D7S486/CEP 7 FISH PROBE KIT

Device Classification Name

dna fish probe kit for specimen characterization, human chromosome, hematological disorders

510(k) Number K131508
Device Name VYSIS D7S486/CEP 7 FISH PROBE KIT
Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, 
IL 
60018

Applicant Contact nancy w bengtson
Correspondent
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, 
IL 
60018

Correspodent Contact nancy w bengtson
Regulation Number 864.1870
Classification Product Code
PFG  
Date Received 05/24/2013
Decision Date 09/13/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No