FDA 510(k) Application Details - K050338

Device Classification Name Flame Photometry, Lithium

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510(K) Number K050338
Device Name Flame Photometry, Lithium
Applicant Akers Biosciences, Inc.
201 GROVE RD.
THOROFARE, NJ 08086 US
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Contact ERIKA AMMIRATI
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Regulation Number 862.3560

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Classification Product Code JIH
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Date Received 02/11/2005
Decision Date 03/04/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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