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FDA 510(k) Application Details - K021541
Device Classification Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
More FDA Info for this Device
510(K) Number
K021541
Device Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Applicant
PERKINELMER LIFE SCIENCES
3985 EASTERN RD.
NORTON, OH 44203 US
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Contact
HANK JUSKE
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Regulation Number
862.1555
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Classification Product Code
JNB
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More FDA Info for this Product Code
Date Received
05/10/2002
Decision Date
10/28/2002
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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