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, If, Toxoplasma Gondii
510(k) Number K861122
Device Name THE GOLDEN QUAD TEST (TOXO)
Applicant
Microbiological Research Corp.
P.O. Box 308
Bountiful,  UT  84010
Applicant Contact CAROLE A GOLDEN
Correspondent
Microbiological Research Corp.
P.O. Box 308
Bountiful,  UT  84010
Correspondent Contact CAROLE A GOLDEN
Regulation Number866.3780
Classification Product Code
LJK  
Date Received03/25/1986
Decision Date 02/02/1987
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
-
-