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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igg, Antigen, Antiserum, Control
510(k) Number K893419
Device Name COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)
Applicant
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Applicant Contact QEE C MATTHEWS
Correspondent
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Correspondent Contact QEE C MATTHEWS
Regulation Number866.5510
Classification Product Code
DEW  
Date Received05/02/1989
Decision Date 08/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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