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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media and components, synthetic cell and tissue culture
510(k) Number K883141
Device Name RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120
Applicant
J R SCIENTIFIC
ONE HARTER AVE., SUITE B
P.O. BOX 1937
woodland,  CA  95695
Applicant Contact marilyn g konish
Correspondent
J R SCIENTIFIC
ONE HARTER AVE., SUITE B
P.O. BOX 1937
woodland,  CA  95695
Correspondent Contact marilyn g konish
Regulation Number864.2220
Classification Product Code
KIT  
Date Received07/26/1988
Decision Date 08/15/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
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