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510(k) K900702

MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA by Innotron of Oregon, Inc. — Product Code LGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1990
Date Received
February 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Carbamazepine
Device Class
Class II
Regulation Number
862.3645
Review Panel
TX
Submission Type

Other clearances by Innotron of Oregon, Inc.

  • K903101 — INNOFLUOR (TM) AMIKACIN CALIBRATOR SET (August 22, 1990)
  • K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET (August 9, 1990)
  • K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (April 20, 1990)
  • K900708 — MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR (April 19, 1990)
  • K900703 — MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR (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)
  • K895827 — INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (October 31, 1989)
  • K895828 — INNOFLUOR DIGOXIN REAGENT SET (October 30, 1989)

Other clearances for product code LGI

  • K944063 — FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE (November 10, 1994)
  • K940682 — AXSYM(TM) QUINIDINE (June 21, 1994)