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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 K823871
Device Name TANDEM-E -FER IMMUNOENZYMETRIC KIT
Applicant
HYBRITECH, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HYBRITECH, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number866.5340
Classification Product Code
DBF  
Date Received12/23/1982
Decision Date 02/25/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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