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510(k) K894520

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

K894520 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR CARBAMAZEPINE CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on Aug 28, 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
Aug 28, 1989
Date Received
Jul 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 (Sep 28, 1989)
  • K894523 — FPR GENTAMICIN KIT (Sep 28, 1989)
  • K894518 — FPR AMIKACIN CALIBRATOR KIT (Sep 28, 1989)
  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (Sep 28, 1989)
  • K894522 — FPR DIGOXIN CALIBRATOR KIT (Sep 25, 1989)
  • K894527 — FPR PHENYTOIN KIT (Sep 25, 1989)
  • K894528 — FPR PHENYTOIN CALIBRATOR KIT (Sep 25, 1989)
  • K894521 — FPR DIGOXIN KIT (Sep 25, 1989)
  • K894530 — FPR THEOPHYLLINE CALIBRATOR KIT (Sep 18, 1989)
  • K894529 — FPR THEOPHYLLINE KIT (Sep 15, 1989)

Other clearances for product code DLJ

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

FDA data resources