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510(k) K820397

AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM by American Diagnostic Corp. — Product Code LER

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1982
Date Received
February 11, 1982
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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