510(k) K942424

DMA MICROPROTEIN PROCEDURE by Data Medical Associates, Inc. — Product Code CEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1994
Date Received
May 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biuret (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type