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510(k) K061841

QUANTA LITE INTRINSIC FACTOR ELISA by Inova Diagnostics, Inc. — Product Code LIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2006
Date Received
June 29, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Intrinsic Factor Blocking Antibody
Device Class
Class II
Regulation Number
862.1810
Review Panel
CH
Submission Type

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