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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 K844042
Device Name BLOOD DILUTION VIAL
Applicant
American Scientific Products
1430 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact MATHEW J PERRY
Correspondent
American Scientific Products
1430 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact MATHEW J PERRY
Regulation Number864.5200
Classification Product Code
GKL  
Date Received10/17/1984
Decision Date 10/23/1984
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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