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 Igg (Fc Fragment Specific), Antigen, Antiserum, Control
510(k) Number K761156
Device Name AMINOGLYCOSIDE CONTROLS
Applicant
Supelco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Supelco, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5530
Classification Product Code
DAS  
Date Received11/29/1976
Decision Date 12/09/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-