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FDA 510(k) Application Details - K984326
Device Classification Name
Radioimmunoassay, Immunoglobulins (D, E)
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510(K) Number
K984326
Device Name
Radioimmunoassay, Immunoglobulins (D, E)
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250-0457 US
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Contact
PRISCILLA A HAMILL
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Regulation Number
866.5510
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Classification Product Code
JHR
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Date Received
12/03/1998
Decision Date
02/08/1999
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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