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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K926124
Device Name CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
Applicant
Coulter Corp.
(31-B08)
P.O. Box 169015
Maimi,  FL  33116
Applicant Contact GREGORY M BUTCHKO
Correspondent
Coulter Corp.
(31-B08)
P.O. Box 169015
Maimi,  FL  33116
Correspondent Contact GREGORY M BUTCHKO
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received12/04/1992
Decision Date 07/06/1993
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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