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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 K860172
Device Name QWIKSPIN (TM)
Applicant
Norfolk Scientific, Inc.
85 Morse St.
Norwood,  MA  02062
Applicant Contact THOMAS F KELLEY,PHD
Correspondent
Norfolk Scientific, Inc.
85 Morse St.
Norwood,  MA  02062
Correspondent Contact THOMAS F KELLEY,PHD
Regulation Number862.2050
Classification Product Code
JQC  
Date Received01/17/1986
Decision Date 02/11/1986
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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