FDA 510(k) Application Details - K841821

Device Classification Name Radioimmunoassay, Human Chorionic Gonadotropin

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510(K) Number K841821
Device Name Radioimmunoassay, Human Chorionic Gonadotropin
Applicant TRAVENOL LABORATORIES, S.A.

, US
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Regulation Number 862.1155

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Classification Product Code JHI
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Date Received 05/02/1984
Decision Date 06/22/1984
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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