FDA 510(k) Application Details - K912858

Device Classification Name Radioimmunoassay, Human Growth Hormone

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510(K) Number K912858
Device Name Radioimmunoassay, Human Growth Hormone
Applicant LONDON DIAGNOSTICS, INC.
10300 VALLEY VIEW RD.
SUITE 107
EDEN PRAIRIE, MN US
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Contact RAMAKRISHNAN
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Regulation Number 862.1370

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Classification Product Code CFL
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Date Received 06/28/1991
Decision Date 07/30/1991
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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