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510(k) K930679

DIRECT BILIRUBIN by Horizon Diagnostics, Inc. — Product Code CIG

K930679 is an FDA 510(k) premarket notification submitted by Horizon Diagnostics, Inc. for the device "DIRECT BILIRUBIN". The FDA issued a decision of Substantially Equivalent on June 29, 1993. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Horizon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1993
Date Received
February 9, 1993
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 Horizon Diagnostics, Inc.

  • K971566 — CREATINE KINASE-MB REAGENT SET (July 14, 1997)
  • K933722 — HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT (June 13, 1996)
  • K935712 — IRON/TIBC REAGENT (September 20, 1995)
  • K930678 — AMYLASE (April 6, 1994)
  • K934533 — BUN-300/BUN-500 UREA NITROGEN REAGENT (November 26, 1993)
  • K930074 — IN-VITRO DIAGNOSTIC REAGENT SET (May 11, 1993)

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