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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K844798
Device Name EPPENDORF DILUTER
Applicant
Medical Technomics, Ltd.
770-D N. Church Rd.
Elmhurst,  IL  60126
Applicant Contact DENNIS A ALDRED
Correspondent
Medical Technomics, Ltd.
770-D N. Church Rd.
Elmhurst,  IL  60126
Correspondent Contact DENNIS A ALDRED
Regulation Number862.2750
Classification Product Code
JQW  
Date Received12/11/1984
Decision Date 01/07/1985
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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