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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K863345
Device Name TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
Applicant
HYBRITECH, INC.
11095 TORREYANA RD.
P.O. BOX 269006
SAN DIEGO,  CA  92126
Applicant Contact BRUNI, PH.D.
Correspondent
HYBRITECH, INC.
11095 TORREYANA RD.
P.O. BOX 269006
SAN DIEGO,  CA  92126
Correspondent Contact BRUNI, PH.D.
Regulation Number866.5340
Classification Product Code
DBF  
Date Received08/29/1986
Decision Date 10/08/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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