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510(k) K902243

TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES by Technicon Instruments Corp. — Product Code KLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1990
Date Received
May 18, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

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