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510(k) K875161

MAT (TM) MICROALBUMIN TEST by Wampole Laboratories — Product Code DCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1988
Date Received
December 15, 1987
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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