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510(k) K003327

ALBUMIN by Jas Diagnostics, Inc. — Product Code CIX

K003327 is an FDA 510(k) premarket notification submitted by Jas Diagnostics, Inc. for the device "ALBUMIN". The FDA issued a decision of Substantially Equivalent on December 5, 2000. The device falls under product code CIX (Bromcresol Green Dye-Binding, Albumin), a Class II device regulated under 21 CFR 862.1035. Jas Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2000
Date Received
October 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
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 CIX

  • K251157 — Core Metabolic (January 9, 2026)
  • K203248 — Albumin BCG2 (November 23, 2021)
  • K200898 — Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medic (September 21, 2021)
  • K191316 — VITROS XT Chemistry Products ALB-TP Slides (June 7, 2019)
  • K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 (April 13, 2018)
  • K131488 — ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND (August 19, 2013)
  • K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE P (July 13, 2012)
  • K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEI (September 8, 2011)
  • K110830 — ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELI (June 21, 2011)
  • K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT (April 4, 2011)

FDA data resources