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 Antisera, Control For Nontreponemal Tests
510(k) Number K885298
Device Name VISUWELL REAGIN TEST 960 TEST KIT
Applicant
Allelix Diagnostics, Inc.
6850 Goreway Dr.
Mississauga, Ontario
Canada L4v 1p1,  CA
Applicant Contact JANET SHAW
Correspondent
Allelix Diagnostics, Inc.
6850 Goreway Dr.
Mississauga, Ontario
Canada L4v 1p1,  CA
Correspondent Contact JANET SHAW
Regulation Number866.3820
Classification Product Code
GMP  
Date Received12/27/1988
Decision Date 03/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-