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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
Applicant Contact CATHY P CRAFT
Correspondent
Dade Chemistry Systems, Inc.
P.O. Box 6101, Glasgow Bldg.
500 Mailbox 514
Newark,  DE  19714
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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