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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K920809
Device Name KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
Applicant
King Diagnostics, Inc.
6856 Hawthorn Park Dr.
Indianapolis,  IN  46220
Applicant Contact FRANCES LOH
Correspondent
King Diagnostics, Inc.
6856 Hawthorn Park Dr.
Indianapolis,  IN  46220
Correspondent Contact FRANCES LOH
Regulation Number862.1150
Classification Product Code
JIS  
Date Received02/21/1992
Decision Date 04/17/1992
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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