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FDA 510(k) Application Details - K163554
Device Classification Name
Reagent, Occult Blood
More FDA Info for this Device
510(K) Number
K163554
Device Name
Reagent, Occult Blood
Applicant
Immunostics, Inc.
1750 Brielle Ave., AS
Ocean, NJ 07712 US
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Contact
Antoinette Prusik
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Regulation Number
864.6550
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Classification Product Code
KHE
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More FDA Info for this Product Code
Date Received
12/19/2016
Decision Date
01/17/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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