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FDA 510(k) Application Details - K120497
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K120497
Device Name
Assay, Glycosylated Hemoglobin
Applicant
MEDICA CORP.
5 OAK PARK DRIVE
BEDFORD, MA 01730 US
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Contact
Photios Makris
Other 510(k) Applications for this Contact
Regulation Number
864.7470
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Classification Product Code
LCP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/21/2012
Decision Date
05/14/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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