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510(k) K152343

Direct Bilirubin by Randox Laboratories Limited — Product Code JFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2016
Date Received
August 19, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Method, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

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Other clearances for product code JFM

  • K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) (March 9, 2017)
  • K152344 — Total Bilirubin (January 28, 2016)
  • K063845 — ADVIA CHEMISTRY TOTAL BILIRUBIN_2 (December 7, 2007)
  • K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 (December 30, 2005)
  • K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 (December 30, 2005)
  • K053090 — DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR (December 16, 2005)
  • K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (June 30, 2005)
  • K970985 — WAKO TOTAL BILIRUBIN V (April 21, 1997)
  • K904660 — ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (November 20, 1990)
  • K843174 — DRI-STAT ENZYMATIC BILIRUBIN TEST KIT (September 14, 1984)