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FDA 510(k) Application Details - K983172
Device Classification Name
Assay, Glycosylated Hemoglobin
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510(K) Number
K983172
Device Name
Assay, Glycosylated Hemoglobin
Applicant
DIABETES TECHNOLOGIES, INC. (DTI)
216 WEST JACKSON ST.
THOMASVILLE, GA 31792 US
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Contact
ARTHUR G WILLIAMS
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
09/10/1998
Decision Date
11/30/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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