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FDA 510(k) Application Details - K181748
Device Classification Name
Photometric Method, Magnesium
More FDA Info for this Device
510(K) Number
K181748
Device Name
Photometric Method, Magnesium
Applicant
Abbott Laboratories
1921 Hurd Drive
Irving, TX 75038 US
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Contact
Mark Littlefield
Other 510(k) Applications for this Contact
Regulation Number
862.1495
More FDA Info for this Regulation Number
Classification Product Code
JGJ
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More FDA Info for this Product Code
Date Received
07/02/2018
Decision Date
09/12/2018
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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