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510(k) K003829

TOTAL BILIRUBIN by Jas Diagnostics, Inc. — Product Code CIG

K003829 is an FDA 510(k) premarket notification submitted by Jas Diagnostics, Inc. for the device "TOTAL BILIRUBIN". The FDA issued a decision of Substantially Equivalent on February 12, 2001. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Jas Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2001
Date Received
December 11, 2000
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 Jas Diagnostics, Inc.

  • K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK (May 15, 2014)
  • K080623 — CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA (November 17, 2008)
  • K080618 — DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID (May 23, 2008)
  • K022519 — LDL CHOLESTEROL (AUTOMATED) (September 30, 2002)
  • K021671 — JAS HDL CHOLESTEROL (AUTOMATED) REAGENT (July 19, 2002)
  • K020454 — CHEMISTRY CALIBRATOR (April 8, 2002)
  • K020282 — JAS AMYLASE LIQUID REAGENT (February 28, 2002)
  • K013912 — CREATINE KINASE (CK-NAC) (January 18, 2002)
  • K013698 — AST (SGOT) (December 21, 2001)
  • K012332 — JAS CARBON DIOXIDE LIQUID REAGENT (September 6, 2001)

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