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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuge, Hematocrit
510(k) Number K920759
Device Name CRITSPIN MICRO-HEMATOCRIT
Applicant
Stat-Spin Technologies
85 Morse St.
Norwood,  MA  02062
Applicant Contact THOMAS F KELLEY
Correspondent
Stat-Spin Technologies
85 Morse St.
Norwood,  MA  02062
Correspondent Contact THOMAS F KELLEY
Regulation Number864.6400
Classification Product Code
GKG  
Date Received02/19/1992
Decision Date 04/29/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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