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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay (two-site solid phase), ferritin
510(k) Number K963498
Device Name FERR FLEX REAGENT CARTRIDGE
Applicant
DADE CHEMISTRY SYSTEMS, INC.
P.O. BOX 6101, GLASGOW BLDG
500 MAILBOX 514
NEWARK,  DE  19714 -6101
Applicant Contact CATHY P CRAFT
Correspondent
DADE CHEMISTRY SYSTEMS, INC.
P.O. BOX 6101, GLASGOW BLDG
500 MAILBOX 514
NEWARK,  DE  19714 -6101
Correspondent Contact CATHY P CRAFT
Regulation Number866.5340
Classification Product Code
JMG  
Date Received09/03/1996
Decision Date 01/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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