FDA 510(k) Application Details - K905592

Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone

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510(K) Number K905592
Device Name Radioimmunoassay, Follicle-Stimulating Hormone
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES, NJ US
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Contact J ARNSBERGER
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Regulation Number 862.1300

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Classification Product Code CGJ
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Date Received 12/13/1990
Decision Date 12/27/1990
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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