510(k) K884217

TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN by Technicon Instruments Corp. — Product Code LKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1988
Date Received
October 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
Review Panel
IM
Submission Type