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510(k) K894519

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

K894519 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR CARBAMAZEPINE KIT". The FDA issued a decision of Substantially Equivalent on Aug 28, 1989. The device falls under product code KLT (Enzyme Immunoassay, Carbamazepine), a Class II device regulated under 21 CFR 862.3645. 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
Enzyme Immunoassay, Carbamazepine
Device Class
Class II
Regulation Number
862.3645
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)
  • K894527 — FPR PHENYTOIN KIT (Sep 25, 1989)
  • K894522 — FPR DIGOXIN CALIBRATOR KIT (Sep 25, 1989)
  • K894521 — FPR DIGOXIN KIT (Sep 25, 1989)
  • K894528 — FPR PHENYTOIN CALIBRATOR KIT (Sep 25, 1989)
  • K894530 — FPR THEOPHYLLINE CALIBRATOR KIT (Sep 18, 1989)
  • K894529 — FPR THEOPHYLLINE KIT (Sep 15, 1989)

Other clearances for product code KLT

  • K151578 — Carbamazepine Gen 4 (Oct 22, 2015)
  • K123518 — ABBOTT CARBAMAZEPINE ASSAY (Jun 5, 2013)
  • K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIB (Oct 14, 2011)
  • K063131 — CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (Oct 5, 2007)
  • K042808 — ADVIA IMS CARBAMAZEPINE METHOD (Feb 8, 2005)
  • K031902 — ONLINE TDM CARBAMAZEPINE (Sep 17, 2003)
  • K011648 — RANDOX CARBAMAZEPINE (Jan 15, 2002)
  • K010814 — EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 (Apr 13, 2001)
  • K000903 — ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (May 18, 2000)
  • K000007 — IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2 (Feb 28, 2000)

FDA data resources