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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 K884031
Device Name FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT
Applicant
Regency Biotech
2469 E. Fort Union Blvd.
Suite 108
Salt Lake City,  UT  84121
Applicant Contact R CORNELIUS
Correspondent
Regency Biotech
2469 E. Fort Union Blvd.
Suite 108
Salt Lake City,  UT  84121
Correspondent Contact R CORNELIUS
Regulation Number864.2220
Classification Product Code
KIT  
Date Received09/23/1988
Decision Date 10/06/1988
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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