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510(k) K821197

TOTAL BILIRUBIN REAGENT SET by Omega Medical Electronics — Product Code CIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1982
Date Received
April 27, 1982
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 Omega Medical Electronics

  • K823691 — PHOSPHORUS REAGENT SET (January 7, 1983)
  • K821206 — SGPT-UV REAGENT SET (July 22, 1982)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)
  • K821204 — GLUCOSE(ENZYMATIC) REAGENT SET (July 22, 1982)
  • K821208 — SGOT-UV REAGENT SET (July 20, 1982)
  • K821201 — LDH-UV REAGENT SET (July 20, 1982)
  • K821205 — TRIGLYCERIDE REAGENT SET (July 20, 1982)
  • K821207 — SGPT REAGENT SET (July 14, 1982)
  • K821209 — SGOT REAGENT SET (July 14, 1982)
  • K821198 — DIRECT GLUCOSE REAGENT SET (July 13, 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)