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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 K872955
Device Name DELFIA(TM) FERRITIN KIT
Applicant
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Applicant Contact ED ZIOR
Correspondent
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Correspondent Contact ED ZIOR
Regulation Number866.5340
Classification Product Code
JMG  
Date Received07/29/1987
Decision Date 08/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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