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510(k) K963840

CEDIA PHENYTOIN II ASSAY by Boehringer Mannheim Corp. — Product Code DIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1996
Date Received
September 24, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K943980 — IL TEST PHENYTION CALIBRATORS (May 1, 1995)
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