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510(k) K831844

DIRECT BILIRUBIN REAGENT by Gilford Diagnostics — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1983
Date Received
June 8, 1983
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 Gilford Diagnostics

  • K832094 — BILIRUBIN CALIBRATORS & CONTROL (August 11, 1983)
  • K831843 — GILCHEM TOTAL BILIRUBIN REAGENT (July 18, 1983)
  • K823709 — TRIGLYCERIDE REAGENT (UV) (January 7, 1983)
  • K822739 — AHBD (October 18, 1982)
  • K822334 — BILIRUBIN CALIBRATORS (September 2, 1982)
  • K822289 — CO2/CI STANDARDS (August 24, 1982)
  • K822149 — GILCHEM Y-GT REAGENT (August 12, 1982)
  • K821719 — AMMONIA REAGENT (June 24, 1982)
  • K820975 — GILCHEM ACID PHOSPHATASE REAGENT (April 26, 1982)
  • K820976 — GIL CHEM MAGNESIUM REAGENT (April 26, 1982)

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)