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510(k) K894523

FPR GENTAMICIN KIT by Colony Laboratories, Inc. — Product Code LCQ

K894523 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR GENTAMICIN KIT". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code LCQ (Fluorescent Immunoassay Gentamicin), a Class II device regulated under 21 CFR 862.3450. Colony Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

Other clearances by Colony Laboratories, Inc.

  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 1989)
  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894522 — FPR DIGOXIN CALIBRATOR KIT (September 25, 1989)
  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K894528 — FPR PHENYTOIN CALIBRATOR KIT (September 25, 1989)
  • K894521 — FPR DIGOXIN KIT (September 25, 1989)
  • K894530 — FPR THEOPHYLLINE CALIBRATOR KIT (September 18, 1989)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K894532 — FPR TOBRAMYCIN CALIBRATOR KIT (September 1, 1989)

Other clearances for product code LCQ

  • K972609 — VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (August 6, 1997)
  • K955569 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (February 9, 1996)
  • K945523 — COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (March 9, 1995)
  • K943550 — GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (November 17, 1994)
  • K905721 — OPUS GENTAMICIN (February 21, 1991)
  • K904226 — 'TDXFLX ANALYZER (October 29, 1990)
  • K852158 — BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA (June 25, 1985)
  • K852013 — GENTAMICIN KIT(FPIA) (June 10, 1985)
  • K843827 — COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (February 1, 1985)
  • K841865 — INNOFLOUR GENTAMICIN (May 31, 1984)

FDA data resources