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FDA 510(k) Application Details - K062658
Device Classification Name
Assay, Glycosylated Hemoglobin
More FDA Info for this Device
510(K) Number
K062658
Device Name
Assay, Glycosylated Hemoglobin
Applicant
PRIMUS CORP.
4231 E. 75TH TERRACE
KANSAS CITY, MO 64132 US
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Contact
BRITT EINSPAHR
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
09/06/2006
Decision Date
11/26/2007
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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