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510(k) K953840

AXSYM PHENYTOIN II by Abbott Laboratories — Product Code LGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1995
Date Received
August 16, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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Other clearances for product code LGR

  • K955873 — ACS PHENYTOIN ASSAY (March 11, 1996)
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  • K936131 — COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (March 11, 1994)
  • K896868 — OPUS PHENYTOIN TEST SYSTEM (January 2, 1990)
  • K895827 — INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (October 31, 1989)
  • K872563 — INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (August 21, 1987)
  • K862554 — IMMPULSE PHENYTOIN ASSAY REAGENT (July 16, 1986)