• 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 strip, test isoniazid
510(k) Number K912888
Device Name URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
Applicant
DYNAGEN, INC.
99 ERIE ST.
cambridge,  MA  02139
Applicant Contact peter j mione
Correspondent
DYNAGEN, INC.
99 ERIE ST.
cambridge,  MA  02139
Correspondent Contact peter j mione
Classification Product Code
MIG  
Date Received07/01/1991
Decision Date 02/24/1992
Decision substantially equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-