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510(k) K895827

INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET by Innotron of Oregon, Inc. — Product Code LGR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
October 2, 1989
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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  • K900708 — MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR (April 19, 1990)
  • K900703 — MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR (April 12, 1990)
  • K900702 — MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (April 12, 1990)
  • K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (April 12, 1990)
  • K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (April 12, 1990)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K895828 — INNOFLUOR DIGOXIN REAGENT SET (October 30, 1989)

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  • K935375 — AXSYM PHENYTOIN ASSAY (June 21, 1994)
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  • K896868 — OPUS PHENYTOIN TEST SYSTEM (January 2, 1990)
  • K872563 — INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (August 21, 1987)
  • K862554 — IMMPULSE PHENYTOIN ASSAY REAGENT (July 16, 1986)