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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Products, Red-Cell Lysing Products
510(k) Number K883836
Device Name COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
Applicant
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Applicant Contact LEE C MATTHEWS
Correspondent
Coulter Immunology
440 Coulter Way
West 20th St.
Hialeah,  FL  33010
Correspondent Contact LEE C MATTHEWS
Regulation Number864.8540
Classification Product Code
GGK  
Date Received09/12/1988
Decision Date 11/30/1988
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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