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FDA 510(k) Application Details - K050338
Device Classification Name
Flame Photometry, Lithium
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
862.3560
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Classification Product Code
JIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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