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510(k) K894522

FPR DIGOXIN CALIBRATOR KIT by Colony Laboratories, Inc. — Product Code DLJ

K894522 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR DIGOXIN CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on September 25, 1989. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Colony Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1989
Date Received
July 20, 1989
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 Colony Laboratories, Inc.

  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 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 DLJ

  • K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPIN (August 8, 2013)
  • K091617 — QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (July 17, 2009)
  • K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (August 22, 2008)
  • K062182 — DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (September 14, 2006)
  • K062199 — DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (September 6, 2006)
  • K061503 — DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (June 22, 2006)
  • K060503 — DIMENSION TACR CALIBRATOR, MODEL DC107 (May 18, 2006)
  • K053108 — DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (February 16, 2006)
  • K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (September 12, 2005)
  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)

FDA data resources