FDA 510(k) Application Details - K172257

Device Classification Name Radioimmunoassay, Human Chorionic Gonadotropin

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510(K) Number K172257
Device Name Radioimmunoassay, Human Chorionic Gonadotropin
Applicant True Diagnostics, Inc
2782 Loker Ave West
Carlsbad, CA 92010 US
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Contact Jerry Lee
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Regulation Number 862.1155

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Classification Product Code JHI
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Date Received 07/26/2017
Decision Date 12/22/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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