Home / 510(k) Clearances / K030003

510(k) K030003

ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR by Elan Diagnostics — Product Code CIG

K030003 is an FDA 510(k) premarket notification submitted by Elan Diagnostics for the device "ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR". The FDA issued a decision of Substantially Equivalent on September 29, 2003. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Elan Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2003
Date Received
January 2, 2003
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 Elan Diagnostics

  • K030014 — ATAC TOTAL BILIRUBIN REAGENT (September 26, 2003)
  • K030621 — ATAC CALIBRATOR (March 19, 2003)
  • K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR (March 13, 2003)
  • K030010 — ATAC PAK MAGNESIUM REAGENT (March 10, 2003)
  • K030015 — ATAC PAK PHOSPHORUS REAGENT (March 7, 2003)
  • K030006 — ATAC PAK ALBUMIN REAGENT (March 7, 2003)
  • K023407 — ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR (February 14, 2003)
  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
  • K020575 — ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS (April 12, 2002)
  • K002285 — ATAC PAK ALP REAGENT KIT (September 26, 2000)

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