510(k) K900943

MODIFIED TECHNICON DPA-1(TM) SYSTEM by Technicon Instruments Corp. — Product Code DEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1990
Date Received
February 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type