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FDA 510(k) Application Details - K990552
Device Classification Name
Radioimmunoassay, Immunoglobulins (G, A, M)
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510(K) Number
K990552
Device Name
Radioimmunoassay, Immunoglobulins (G, A, M)
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
ROUTE 896, GLASGOW BLDG. 500
NEWARK, DE 19714-6101 US
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Contact
CATHY P CRAFT
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Regulation Number
866.5510
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Classification Product Code
CFQ
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More FDA Info for this Product Code
Date Received
02/22/1999
Decision Date
03/25/1999
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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