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510(k) K900707

MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR by Innotron of Oregon, Inc. — Product Code LFW

K900707 is an FDA 510(k) premarket notification submitted by Innotron of Oregon, Inc. for the device "MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR". The FDA issued a decision of Substantially Equivalent on April 20, 1990. The device falls under product code LFW (Fluorescence Polarization Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Innotron of Oregon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1990
Date Received
February 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
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)
  • K900708 — MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR (April 19, 1990)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K900703 — MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR (April 12, 1990)
  • K900705 — MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (April 12, 1990)
  • K900702 — MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (April 12, 1990)
  • K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE 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 LFW

  • K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (February 4, 1997)
  • K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR (November 10, 1994)
  • K941614 — AXSYM TOBRAMYCIN (August 18, 1994)
  • K912143 — CEDIA(R) TOBRAMYCIN ASSAY (July 26, 1991)
  • K894531 — FPR TOBRAMYCIN KIT (September 1, 1989)
  • K872562 — INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET (August 17, 1987)
  • K854392 — TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU (December 5, 1985)
  • K843828 — COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA (February 1, 1985)
  • K841866 — INNOFLOUR TOBRAMYCIN (May 31, 1984)

FDA data resources