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510(k) K884002

ANALYST THEOPHYLLINE ROTOR by The DU Pont Co. — Product Code KLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
September 21, 1988
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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