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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K810833
Device Name SORVALL RT6000 REFRIGERATED TABLETOP
Applicant
E.I. Dupont DE Nemours & Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2050
Classification Product Code
JQC  
Date Received03/25/1981
Decision Date 04/08/1981
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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