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510(k) K080696

ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 by Abbott Laboratories — Product Code DIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2008
Date Received
March 12, 2008
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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  • K993026 — ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS (January 27, 2000)
  • 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)
  • K945725 — PHENYTION EIA TEST (February 3, 1995)