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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Probe, B And T Lymphocyte
510(k) Number K923951
Device Name CD8 CYTOSPHERES KIT
Applicant
Coulter Electronics, Inc.
600 W. 20th St.
Hialeah,  FL  33010
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
600 W. 20th St.
Hialeah,  FL  33010
Correspondent Contact RICHARDSON-JONES
Regulation Number864.5220
Classification Product Code
MAM  
Date Received08/06/1992
Decision Date 04/25/1994
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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