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510(k) K881116

EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 by Diagnostic Systems — Product Code KLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1988
Date Received
March 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Lidocaine
Device Class
Class II
Regulation Number
862.3555
Review Panel
TX
Submission Type

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