510(k) K014193

LIFESIGN DOA 4 (THC/OPI/COC/MET) by Princeton BioMeditech Corp. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2002
Date Received
December 21, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type