FDA 510(k) Application Details - K811637

Device Classification Name Free Radical Assay, Morphine

  More FDA Info for this Device
510(K) Number K811637
Device Name Free Radical Assay, Morphine
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON, DC US
Other 510(k) Applications for this Company
Regulation Number 862.3640

  More FDA Info for this Regulation Number
Classification Product Code DOK
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/10/1981
Decision Date 08/13/1981
Decision SE - Substantially Equivalent
Classification Advisory Committee MI - Microbiology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact