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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 K883367
Device Name CALF SERUM, CATALOG NO. 110-1125
Applicant
J R Scientific
One Harter Ave., Suite B
P.O. Box 1937
Woodland,  CA  95695
Applicant Contact G KONISH,PHD
Correspondent
J R Scientific
One Harter Ave., Suite B
P.O. Box 1937
Woodland,  CA  95695
Correspondent Contact G KONISH,PHD
Regulation Number864.2220
Classification Product Code
KIT  
Date Received08/09/1988
Decision Date 08/29/1988
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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