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510(k) K903101

INNOFLUOR (TM) AMIKACIN CALIBRATOR SET by Innotron of Oregon, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
July 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Innotron of Oregon, Inc.

  • 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)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (April 12, 1990)
  • K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (April 12, 1990)
  • K900702 — MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (April 12, 1990)
  • K895827 — INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (October 31, 1989)
  • K895828 — INNOFLUOR DIGOXIN REAGENT SET (October 30, 1989)

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  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)