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510(k) K882570

TURBOX THEOPHYLLINE ASSAY by Unipath , Ltd. — Product Code LER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1988
Date Received
June 22, 1988
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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  • K831514 — AMWA TDA THEOPHYLLINE TEST (June 30, 1983)
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