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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 K841803
Device Name A1 SYSTEME 8201/2
Applicant
Med USA
319 Waverley Oaks Rd.
Waltham,  MA  02154
Applicant Contact JAMES R RUNDELL
Correspondent
Med USA
319 Waverley Oaks Rd.
Waltham,  MA  02154
Correspondent Contact JAMES R RUNDELL
Regulation Number864.5200
Classification Product Code
GKL  
Date Received05/01/1984
Decision Date 02/25/1985
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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