FDA 510(k) Application Details - K842092

Device Classification Name Enzyme Immunoassay, Diphenylhydantoin

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510(K) Number K842092
Device Name Enzyme Immunoassay, Diphenylhydantoin
Applicant MILES LABORATORIES, INC.
P.O. BOX 40
ELKHART, IN US
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Contact H ENGELMANN
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Regulation Number 862.3350

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Classification Product Code DIP
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Date Received 05/24/1984
Decision Date 03/19/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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