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510(k) K013102

WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 by Wiener Laboratories Saic — Product Code JMO

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
Ferrozine (Colorimetric) Iron Binding Capacity
Device Class
Class I
Regulation Number
862.1415
Review Panel
CH
Submission Type

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