510(k) K891167

COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT by Diagnostic Products Corp. — Product Code DLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1989
Date Received
March 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Lsd (125-I)
Device Class
Class II
Regulation Number
862.3580
Review Panel
TX
Submission Type