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FDA 510(k) Application Details - K955025
Device Classification Name
Radioimmunoassay, Progesterone
More FDA Info for this Device
510(K) Number
K955025
Device Name
Radioimmunoassay, Progesterone
Applicant
ABBOTT LABORATORIES
100 ABBOTT MALL
BUFFALO, NY 14225 US
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Contact
JOY C SONSALLA
Other 510(k) Applications for this Contact
Regulation Number
862.1620
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Classification Product Code
JLS
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More FDA Info for this Product Code
Date Received
11/02/1995
Decision Date
03/07/1996
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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