FDA 510(k) Application Details - K936135

Device Classification Name Radioimmunoassay, Cannabinoid(S)

  More FDA Info for this Device
510(K) Number K936135
Device Name Radioimmunoassay, Cannabinoid(S)
Applicant SUDORMED, INC.
12341 NEWPORT AVE., #D-200
SANTA ANA, CA 92705 US
Other 510(k) Applications for this Company
Contact JON BOOHER, PH.D.
Other 510(k) Applications for this Contact
Regulation Number 862.3870

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

  More FDA Info for this Product Code
Date Received 12/28/1993
Decision Date 06/10/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K936135


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