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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K896206
Device Name STATSPIN STATSAMPLER
Applicant
Statspin Technologies
85 Morse St.
Norwood,  MA  02062
Applicant Contact THOMAS F KELLEY,PHD
Correspondent
Statspin Technologies
85 Morse St.
Norwood,  MA  02062
Correspondent Contact THOMAS F KELLEY,PHD
Regulation Number862.1675
Classification Product Code
JKA  
Date Received10/26/1989
Decision Date 11/22/1989
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
Recalls CDRH Recalls
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