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FDA 510(k) Application Details - K955647
Device Classification Name
Radioimmunoassay, Estradiol
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510(K) Number
K955647
Device Name
Radioimmunoassay, Estradiol
Applicant
BIOMERIEUX VITEK, INC.
1022 HINGHAM ST.
ROCKLAND, MA 02370 US
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Contact
TERRY MCGOVERN
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Regulation Number
862.1260
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Classification Product Code
CHP
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More FDA Info for this Product Code
Date Received
12/12/1995
Decision Date
02/06/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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