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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K884485
Device Name KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
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 Number864.7925
Classification Product Code
GFO  
Date Received10/25/1988
Decision Date 12/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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