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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, Sodium
510(k) Number K891574
Device Name LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact ANNA G BENTLEY
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact ANNA G BENTLEY
Regulation Number862.1665
Classification Product Code
JGT  
Date Received03/20/1989
Decision Date 06/09/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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