FDA 510(k) Application Details - K874389

Device Classification Name Thin Layer Chromatography, Cocaine

  More FDA Info for this Device
510(K) Number K874389
Device Name Thin Layer Chromatography, Cocaine
Applicant SAKERS, INC.
PLAZA 47
800 DELSEA DRIVE, SUITE 10
WESTVILLE, NJ US
Other 510(k) Applications for this Company
Contact AKERS, JR
Other 510(k) Applications for this Contact
Regulation Number 862.3250

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

  More FDA Info for this Product Code
Date Received 10/27/1987
Decision Date 02/07/1989
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
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