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510(k) K840486

TOTAL BILIRUBIN REAGENT by Somas Medical Industries, Inc. — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
February 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo Colorimetry, Bilirubin
Device Class
Class II
Regulation Number
862.1110
Review Panel
CH
Submission Type

Other clearances by Somas Medical Industries, Inc.

  • K862179 — SOMAS LIQUID URINE CONTROL (July 1, 1986)
  • K842134 — SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (July 6, 1984)
  • K840974 — SOMAS HUMAN SPINAL FLUID CONTROL (April 5, 1984)
  • K840485 — TOTAL IRON UIBC/TIBC ASSAY (March 12, 1984)
  • K833787 — SOMAS CHLORIDE ASSAY KIT (January 11, 1984)

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  • K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides (April 26, 2019)
  • K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN (July 11, 2017)
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  • K131544 — COBAS C BILIRUBIN TOTAL GEN.3 (July 17, 2013)
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