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FDA 510(k) Application Details - K991244
Device Classification Name
Ferrozine (Colorimetric) Iron Binding Capacity
More FDA Info for this Device
510(K) Number
K991244
Device Name
Ferrozine (Colorimetric) Iron Binding Capacity
Applicant
A.P. TOTAL CARE, INC.
70 HAWLEY AVE,
PO BOX 6216
BRIDGEPORT, CT US
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Contact
LUIS P LEON
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Regulation Number
862.1415
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Classification Product Code
JMO
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More FDA Info for this Product Code
Date Received
04/12/1999
Decision Date
05/25/1999
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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