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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cells, Animal And Human, Cultured
510(k) Number K864776
Device Name A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
Applicant
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact HOWARD TAYLOR
Correspondent
Bartels Immunodiagnostic Supplies, Inc.
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact HOWARD TAYLOR
Regulation Number864.2280
Classification Product Code
KIR  
Date Received12/08/1986
Decision Date 12/31/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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