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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Platelet Counting
510(k) Number K843910
Device Name COULTER MEAN PLATELET VOLUME CALIBRATOR
Applicant
Coulter Electronics, Inc.
590 W. 20th St.
Hialeah,  FL  33010
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
590 W. 20th St.
Hialeah,  FL  33010
Correspondent Contact RICHARDSON-JONES
Regulation Number864.8175
Classification Product Code
KRY  
Date Received10/03/1984
Decision Date 01/07/1985
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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