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 K923463
Device Name CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT
Applicant
Techlab, Inc.
555 13th St.
Suite 1109
Washington,  DC  20004
Applicant Contact PATRICIA SHRADER
Correspondent
Techlab, Inc.
555 13th St.
Suite 1109
Washington,  DC  20004
Correspondent Contact PATRICIA SHRADER
Regulation Number866.2660
Classification Product Code
LLH  
Date Received07/14/1992
Decision Date 02/01/1993
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
-
-