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510(k) K030428

ROCHE ONLINE TDM PHENYTOIN by Roche Diagnostics Corp. — Product Code DIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2003
Date Received
February 10, 2003
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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Other clearances for product code DIP

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  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K963840 — CEDIA PHENYTOIN II ASSAY (November 20, 1996)
  • K943980 — IL TEST PHENYTION CALIBRATORS (May 1, 1995)
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