FDA 510(k) Application Details - K943188

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K943188
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant SEALITE SCIENCES, INC.
187 BEN BURTON CIRCLE
BOGART, GA US
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Contact DAVID F SMITH
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 07/05/1994
Decision Date 10/20/1994
Decision SE - Substantially Equivalent
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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