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510(k) K894531

FPR TOBRAMYCIN KIT by Colony Laboratories, Inc. — Product Code LFW

K894531 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR TOBRAMYCIN KIT". The FDA issued a decision of Substantially Equivalent on September 1, 1989. The device falls under product code LFW (Fluorescence Polarization Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Colony Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1989
Date Received
July 20, 1989
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 Colony Laboratories, Inc.

  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 1989)
  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894521 — FPR DIGOXIN KIT (September 25, 1989)
  • K894522 — FPR DIGOXIN CALIBRATOR KIT (September 25, 1989)
  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K894528 — FPR PHENYTOIN CALIBRATOR KIT (September 25, 1989)
  • K894530 — FPR THEOPHYLLINE CALIBRATOR KIT (September 18, 1989)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 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)
  • K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (April 20, 1990)
  • 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