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FDA 510(k) Application Details - K960067
Device Classification Name
Radioimmunoassay, Immunoglobulins (D, E)
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510(K) Number
K960067
Device Name
Radioimmunoassay, Immunoglobulins (D, E)
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact
EDWARD M LEVINE, PH.D.
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Regulation Number
866.5510
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Classification Product Code
JHR
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More FDA Info for this Product Code
Date Received
01/05/1996
Decision Date
02/14/1996
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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