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510(k) K914391

ALBUMIN TEST RID KIT by The Binding Site, Ltd. — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1991
Date Received
October 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type

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