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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 K803128
Device Name SERIES 810 PLATELET ANALYZER
Applicant
J.T. Baker Chemical Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
J.T. Baker Chemical Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.5200
Classification Product Code
GKL  
Date Received12/12/1980
Decision Date 04/03/1981
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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