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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 K881254
Device Name STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
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 Received03/23/1988
Decision Date 04/05/1988
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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