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FDA 510(k) Application Details - K964748
Device Classification Name
Radioimmunoassay, Prolactin (Lactogen)
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510(K) Number
K964748
Device Name
Radioimmunoassay, Prolactin (Lactogen)
Applicant
BOEHRINGER MANNHEIM CORP.
2380A BISSO LN.
CONCORD, CA 94520 US
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Contact
MARY KONING
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Regulation Number
862.1625
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Classification Product Code
CFT
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More FDA Info for this Product Code
Date Received
11/26/1996
Decision Date
01/21/1997
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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