Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 dna-probe kit, human chromosome
510(k) Number K953591
Device Name CEP 8 SPECTRUMORANGE DNA PROBE KIT
Applicant
VYSIS
3100 woodcreek dr.
downers grove,  IL  60515
Applicant Contact russell k enns
Correspondent
VYSIS
3100 woodcreek dr.
downers grove,  IL  60515
Correspondent Contact russell k enns
Regulation Number866.4700
Classification Product Code
OYU  
Subsequent Product Code
KIR  
Date Received08/01/1995
Decision Date 11/29/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-