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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 K844288
Device Name INRA MENEZO B2 MEDIA
Applicant
Fcs Laboratories, Inc.
P.O. Box 129
Whitehouse,  NJ  08888
Applicant Contact JANIS FREESTONE
Correspondent
Fcs Laboratories, Inc.
P.O. Box 129
Whitehouse,  NJ  08888
Correspondent Contact JANIS FREESTONE
Regulation Number864.2220
Classification Product Code
KIT  
Date Received11/05/1984
Decision Date 12/13/1984
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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