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510(k) K010125

INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST by Alfa Scientific Designs, Inc. — Product Code DIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2001
Date Received
November 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

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