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510(k) K080435

OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 by Olympus Life Science Research Europa GmbH (Europa) — Product Code CIG

K080435 is an FDA 510(k) premarket notification submitted by Olympus Life Science Research Europa GmbH (Europa) for the device "OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181". The FDA issued a decision of Substantially Equivalent on September 5, 2008. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Olympus Life Science Research Europa GmbH (Europa) has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2008
Date Received
February 19, 2008
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 Olympus Life Science Research Europa GmbH (Europa)

  • K081709 — OLYMPUS AFP - ALPHA-FETOPROTEIN (March 16, 2009)
  • K080094 — OLYMPUS TOTAL BHCG TEST SYSTEN (September 3, 2008)

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