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510(k) K926245

ABBOTT VISION THEOPHYLLINE IIA by Abbott Laboratories — Product Code KLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1993
Date Received
December 14, 1992
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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