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, Ferritin, Antigen, Antiserum, Control
510(k) Number K830229
Device Name ROENTGENOGRAPHY SET
Applicant
Mallinckrodt Critical Care
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Mallinckrodt Critical Care
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5510
Classification Product Code
DGD  
Date Received01/24/1983
Decision Date 03/09/1983
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
-
-