FDA 510(k) Application Details - K974047

Device Classification Name Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

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510(K) Number K974047
Device Name Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Applicant NEOMETRICS, INC.
104 BELLEROSE AVE.
EAST NORTHPORT, NY 11731 US
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Contact DAVID SCHWARTZ
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Regulation Number 862.1555

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Classification Product Code JNB
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Date Received 10/24/1997
Decision Date 12/05/1997
Decision SESE - SUBST EQUIV
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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