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510(k) K820714

DOW BILIRUBIN(DIRECT) DETERMINATION by The Dow Chemical Co. — Product Code CIG

K820714 is an FDA 510(k) premarket notification submitted by The Dow Chemical Co. for the device "DOW BILIRUBIN(DIRECT) DETERMINATION". The FDA issued a decision of Substantially Equivalent on Apr 1, 1982. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. The Dow Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 1, 1982
Date Received
Mar 15, 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 The Dow Chemical Co.

  • K823474 — ENZYMATIC GLUCOSE DETERMINATION (Dec 30, 1982)
  • K822154 — UREA NITROGEN (ENZYMATIC) DETERMINATION (Aug 5, 1982)
  • K821536 — DOWFLOW ALT-UV DETERMINATION (Jun 14, 1982)
  • K821315 — DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM (May 24, 1982)
  • K820675 — BILIRUBIN(TOTAL) DETERMINATION CTMS (Apr 1, 1982)
  • K812777 — DIRECT IRON REAGENT SET (Oct 19, 1981)
  • K811806 — QUICK-CHEM COLORIMETER (Jul 15, 1981)
  • K810861 — CREATINE KINASE MB ISOENZYME IMMUNO UV (Apr 14, 1981)
  • K810727 — AST-UV (PLP-ACTIVATED) DETERMINATION (Mar 31, 1981)
  • K801501 — UV URIC ACID STANDARDS (Sep 26, 1980)

Other clearances for product code CIG

  • K251998 — Atellica CH Diazo Total Bilirubin (D_TBil) (Feb 27, 2026)
  • K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil) (Jun 12, 2023)
  • K222104 — Atellica® CH Diazo Total Bilirubin (D_TBil) (Mar 20, 2023)
  • K223324 — Total Bilirubin2 (Dec 29, 2022)
  • K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides (Apr 26, 2019)
  • K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN (Jul 11, 2017)
  • K150510 — Total Bilirubin (Apr 2, 2015)
  • K131544 — COBAS C BILIRUBIN TOTAL GEN.3 (Jul 17, 2013)
  • K131217 — S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN (Jun 7, 2013)
  • K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT (Mar 1, 2013)

FDA data resources