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510(k) K000556

ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS by Elan Diagnostics — Product Code CFR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2000
Date Received
February 18, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
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)
  • 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)

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