510(k) K013652

WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002 by Wiener Laboratories Saic — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2001
Date Received
November 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type