510(k) K932209

TOXI*LAB LTD OPIATE SYSTEM by Toxi-Lab, Inc. — Product Code LAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1993
Date Received
May 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type