510(k) K013097

WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 by Wiener Laboratories Saic — Product Code JIY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2001
Date Received
September 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type