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510(k) K173294

Magnesium by Abbott Laboratories — Product Code JGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2018
Date Received
October 16, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Magnesium
Device Class
Class I
Regulation Number
862.1495
Review Panel
CH
Submission Type

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  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K040115 — PICCOLO MAGNESIUM TEST SYSTEM (January 30, 2004)