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510(k) K894529

FPR THEOPHYLLINE KIT by Colony Laboratories, Inc. — Product Code LGS

K894529 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR THEOPHYLLINE KIT". The FDA issued a decision of Substantially Equivalent on September 15, 1989. The device falls under product code LGS (Fluorescence Polarization Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Colony Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
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)
  • 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)
  • K894531 — FPR TOBRAMYCIN KIT (September 1, 1989)

Other clearances for product code LGS

  • K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (June 8, 2007)
  • K955567 — INNOFLUOR THEOPHYLLINE ASSAY SYSTEM (January 24, 1996)
  • K953016 — AXSYM THEOPHYLLINE II (August 24, 1995)
  • K951169 — CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY (June 20, 1995)
  • K942991 — QMS THEOPHYLLINE CS (September 9, 1994)
  • K932127 — TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (August 9, 1993)
  • K922991 — ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE (August 27, 1992)
  • K900706 — MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (April 12, 1990)
  • K871484 — COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (May 28, 1987)
  • K870277 — MONITORX LASERX THEOPHYLLINE REAGENT SET (February 18, 1987)

FDA data resources