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510(k) K030006

ATAC PAK ALBUMIN REAGENT by Elan Diagnostics — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2003
Date Received
January 2, 2003
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 Elan Diagnostics

  • K030003 — ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR (September 29, 2003)
  • 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)
  • 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)

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  • 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)