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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 K850537
Device Name CELL CULTURE REFEED MEDIUM
Applicant
Hillcrest Biologicals
10703 Progress Way
Cypress,  CA  90630
Applicant Contact LOUIS C CULLMAN
Correspondent
Hillcrest Biologicals
10703 Progress Way
Cypress,  CA  90630
Correspondent Contact LOUIS C CULLMAN
Regulation Number864.2220
Classification Product Code
KIT  
Date Received02/11/1985
Decision Date 03/20/1985
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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