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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conversion To Creatinine, Creatine
510(k) Number K852767
Device Name ERYTHOCYTE CREATINE
Applicant
Panmed, Inc.
505 W. Locust
Three Oaks,  MI  49128
Applicant Contact ROGER VERN
Correspondent
Panmed, Inc.
505 W. Locust
Three Oaks,  MI  49128
Correspondent Contact ROGER VERN
Regulation Number862.1210
Classification Product Code
JLA  
Date Received06/28/1985
Decision Date 11/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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