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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuvette, Thermostated
510(k) Number K873656
Device Name MEDATRON CUVETTE DISC
Applicant
Medatron, Inc.
C/O Professional Billing Co.
250 Bishops Way
Brookfield,  WI  53005
Applicant Contact KIM KAUFMANN
Correspondent
Medatron, Inc.
C/O Professional Billing Co.
250 Bishops Way
Brookfield,  WI  53005
Correspondent Contact KIM KAUFMANN
Regulation Number862.2050
Classification Product Code
JRI  
Date Received09/10/1987
Decision Date 12/14/1987
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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