510(k) K022388

STARTOX DRUG OF ABUSE SCREENING TEST (4) by Starplex Scientific, Inc. — Product Code DJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2003
Date Received
July 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thin Layer Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type