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 Fluorometer
510(k) Number K842049
Device Name FLUOROSKAN
Applicant
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Applicant Contact GERALD A HAHN
Correspondent
Flow Laboratories, Inc.
7655 Old Springhouse Rd.
Mclean,  VA  22102
Correspondent Contact GERALD A HAHN
Regulation Number866.4520
Classification Product Code
JZT  
Date Received05/22/1984
Decision Date 12/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-