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 Enzyme Linked Immunoabsorbent Assay, Rotavirus
510(k) Number K834443
Device Name ROTAVIRUS BIO-ENZABEAD SCREEN KIT
Applicant
Litton Bionetics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Litton Bionetics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.3405
Classification Product Code
LIQ  
Date Received12/16/1983
Decision Date 03/16/1984
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
-
-