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510(k) K063845

ADVIA CHEMISTRY TOTAL BILIRUBIN_2 by Bayer Healthcare, LLC — Product Code JFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2007
Date Received
December 27, 2006
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)
  • K152343 — Direct Bilirubin (February 16, 2016)
  • K152344 — Total Bilirubin (January 28, 2016)
  • 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)