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FDA 510(k) Application Details - K030553
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K030553
Device Name
Assay, Glycosylated Hemoglobin
Applicant
ARKRAY, INC.
2320 SCIENTIFIC PARK DR.
WILMINGTON, NC 28405 US
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Contact
GARY M HAIGHT
Other 510(k) Applications for this Contact
Regulation Number
864.7470
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Classification Product Code
LCP
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More FDA Info for this Product Code
Date Received
02/21/2003
Decision Date
09/02/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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