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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K864611
Device Name IMMUNO-SURE
Applicant
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Correspondent Contact RICHARDSON-JONES
Date Received11/24/1986
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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