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510(k) K943980

IL TEST PHENYTION CALIBRATORS by Instrumentation Laboratory CO — Product Code DIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1995
Date Received
June 7, 1994
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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  • K030428 — ROCHE ONLINE TDM PHENYTOIN (April 28, 2003)
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  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
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  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K963840 — CEDIA PHENYTOIN II ASSAY (November 20, 1996)
  • K945725 — PHENYTION EIA TEST (February 3, 1995)