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510(k) K840486

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

K840486 is an FDA 510(k) premarket notification submitted by Somas Medical Industries, Inc. for the device "TOTAL BILIRUBIN REAGENT". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Somas Medical Industries, Inc. has at least 5 other 510(k) clearances on record.

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)

Other clearances for product code CIG

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (February 27, 2026)
  • K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil) (June 12, 2023)
  • K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil) (March 20, 2023)
  • K223324 — Total Bilirubin2 (December 29, 2022)
  • 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)
  • K150510 — Total Bilirubin (April 2, 2015)
  • K131544 — COBAS C BILIRUBIN TOTAL GEN.3 (July 17, 2013)
  • K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (June 7, 2013)
  • K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (March 1, 2013)

FDA data resources