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FDA 510(k) Application Details - K190335
Device Classification Name
Enzymatic Methods, Galactose
More FDA Info for this Device
510(K) Number
K190335
Device Name
Enzymatic Methods, Galactose
Applicant
PerkinElmer Inc.
940 Winter Street
Waltham, MA 02451 US
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Contact
Brian Ciccariello
Other 510(k) Applications for this Contact
Regulation Number
862.1310
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Classification Product Code
JIA
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More FDA Info for this Product Code
Date Received
02/14/2019
Decision Date
11/06/2019
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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