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 Reagents, Clostridium Difficile Toxin
510(k) Number K863485
Device Name MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
Applicant
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Applicant Contact GUINTY, JR
Correspondent
Marion Laboratories, Inc.
P.O. Box 9627
Kansas City,  MI  64134
Correspondent Contact GUINTY, JR
Regulation Number866.2660
Classification Product Code
LLH  
Date Received09/09/1986
Decision Date 09/17/1986
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
-
-