FDA 510(k) Application Details - K811993

Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone

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510(K) Number K811993
Device Name Radioimmunoassay, Follicle-Stimulating Hormone
Applicant ENDOCRINE-METABOLIC CENTER

, US
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Regulation Number 862.1300

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Classification Product Code CGJ
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Date Received 07/14/1981
Decision Date 08/03/1981
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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