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 Immunohistochemistry Assay, Antibody, Progesterone Receptor
510(k) Number K062615
Device Name VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16
Applicant
Vision Biosystems, Inc.
1833 Portola Rd.
Ventura,  CA  93003
Applicant Contact RONALD F LAGERQUIST
Correspondent
Vision Biosystems, Inc.
1833 Portola Rd.
Ventura,  CA  93003
Correspondent Contact RONALD F LAGERQUIST
Regulation Number864.1860
Classification Product Code
MXZ  
Date Received09/05/2006
Decision Date 01/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-