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510(k) K953840

AXSYM PHENYTOIN II by Abbott Laboratories — Product Code LGR

K953840 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "AXSYM PHENYTOIN II". The FDA issued a decision of Substantially Equivalent on September 25, 1995. The device falls under product code LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)), a Class II device regulated under 21 CFR 862.3350. Abbott Laboratories has at least 10 other 510(k) clearances on record.

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)
  • K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEM (January 24, 1996)
  • K946328 — TDX(R)/TDXFLX(R) PHENYTOIN II (March 28, 1995)
  • K943313 — PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (October 27, 1994)
  • K935375 — AXSYM PHENYTOIN ASSAY (June 21, 1994)
  • 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)

FDA data resources