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510(k) K902952

IL PHENYTOIN ASSAY SYSTEM by Instrumentation Laboratory CO — Product Code DIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
July 5, 1990
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)
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