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FDA 510(k) Application Details - K993273
Device Classification Name
Ferritin, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K993273
Device Name
Ferritin, Antigen, Antiserum, Control
Applicant
DADE BEHRING, INC.
GLASGOW BUSINESS COMMUNITY;
BLDG. 500 MAIL BOX 514
P.O. BOX 6101, NEWARK, DE 19714-6101 US
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Contact
REBECCA S AYASH
Other 510(k) Applications for this Contact
Regulation Number
866.5340
More FDA Info for this Regulation Number
Classification Product Code
DBF
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More FDA Info for this Product Code
Date Received
09/30/1999
Decision Date
11/23/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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