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510(k) K905521

CEDIA(R) THEOPHYLLINE ASSAY/MODIFICATION by Microgenics Corp. — Product Code LER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1990
Date Received
December 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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