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 Exoenzymes, Multiple, Streptococcal
510(k) Number K833738
Device Name LEAP STREP TEST KIT
Applicant
Cooper Biomedical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cooper Biomedical, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3720
Classification Product Code
GTP  
Date Received10/25/1983
Decision Date 12/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-