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510(k) K981581

IRON by Abbott Laboratories — Product Code CFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1998
Date Received
May 4, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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