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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K900788
Device Name MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
Applicant
Datachem, Inc.
7742 Moller Rd.
Indianapolis,  IN  46268
Applicant Contact WALLACE, PHD
Correspondent
Datachem, Inc.
7742 Moller Rd.
Indianapolis,  IN  46268
Correspondent Contact WALLACE, PHD
Regulation Number862.1600
Classification Product Code
CEM  
Date Received02/20/1990
Decision Date 07/05/1990
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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