510(k) K905790

TOTAL PROTEIN REAGENT SET by Biochemical Trade, Inc. — Product Code CEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1991
Date Received
December 27, 1990
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