FDA 510(k) Application Details - K173294

Device Classification Name Photometric Method, Magnesium

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510(K) Number K173294
Device Name Photometric Method, Magnesium
Applicant Abbott Laboratories
1921 Hurd Drive
Irving, TX 75038 US
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Contact Kimberly Senseman
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Regulation Number 862.1495

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Classification Product Code JGJ
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Date Received 10/16/2017
Decision Date 05/18/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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