FDA 510(k) Application Details - K850530

Device Classification Name Radioimmunoassay, Human Chorionic Gonadotropin

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510(K) Number K850530
Device Name Radioimmunoassay, Human Chorionic Gonadotropin
Applicant LEECO DIAGNOSTICS, INC.
21705 EVERGREEN
P.O. BOX 5126
SOUTHFIELD, MI US
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Contact JAMES P LEE
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Regulation Number 862.1155

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Classification Product Code JHI
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Date Received 02/11/1985
Decision Date 04/02/1985
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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