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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flame Photometry, Lithium
510(k) Number K050338
FOIA Releasable 510(k) K050338
Device Name MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
Applicant
Akers Biosciences, Inc.
201 Grove Rd.
Thorofare,  NJ  08086
Applicant Contact ERIKA AMMIRATI
Correspondent
Akers Biosciences, Inc.
201 Grove Rd.
Thorofare,  NJ  08086
Correspondent Contact ERIKA AMMIRATI
Regulation Number862.3560
Classification Product Code
JIH  
Date Received02/11/2005
Decision Date 03/04/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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