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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K872145
Device Name CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)
Applicant
Cryo Corp.
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact THOMAS O HENTELEFF
Correspondent
Cryo Corp.
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact THOMAS O HENTELEFF
Regulation Number864.5200
Classification Product Code
GKL  
Date Received06/04/1987
Decision Date 11/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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